Webinar Search Results : 125 Upcoming webinars found.
Mark Brengelman Friday, January 18, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Mark Brengelman
Regulation of the Practice of Geology in the United States
Today's educated professionals in the earth sciences function in a maze of different educational and training requirements, which vary from state to state and from profession to profession.

Lena Cordie Tuesday, January 22, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Lena Cordie
Software Verification & Validation
Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood.

Tom Fragale Tuesday, January 22, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Tom Fragale
Going from Raw Data to Great Results with Excel PowerPivot and PowerQuery
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources. Luckily there are two Microsoft tools- PowerPivot and PowerQuery-that solve ALL of these issues, right inside Excel.

Robert J. Russell Tuesday, January 22, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Robert J. Russell
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Angela Bazigos Wednesday, January 23, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

Ben Woodcock Wednesday, January 23, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Ben Woodcock
Why Humans Error and What We can do About it
Every system has a goal. Some systems may have more than one. The purpose of each part of a system is to successfully execute its task or tasks in order to support achieving that system goal or goals.

John N. Zorich Wednesday, January 23, 2019
10:00 AM PST | 01:00 PM EST
Duration:2 Hours
Price: ¤190.00
by: John N. Zorich
2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Peggy Berry Wednesday, January 23, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Peggy Berry
Complaint Handling
The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Michael Esposito Wednesday, January 23, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Michael Esposito
Packaging and Labelling in the Pharmaceutical Supply Chain
Packaging and Labeling form a bridge between the conception of a product and its realization and distribution, and consequently occupy a critical position in the success or failure of any pharmaceutical product launch or revision. Decision-makers need at least a cursory knowledge of potential pitfalls to create contingencies, as it is easier and more cost-effective to change things earlier in process than later.

Dennis Taylor Thursday, January 24, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dennis Taylor
Time-Saving Excel Tips, Tricks and 100 Shortcuts
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Ginette Collazo Thursday, January 24, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Tools for Human Error Reduction
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Thomas Bento Thursday, January 24, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Thomas Bento
The Value of a Human Factors Program
This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.

Derk Yntema Thursday, January 24, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Derk Yntema
GDPR - European Privacy Regulation what and how
The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

Dr. Afsaneh Motamed Khorasani Thursday, January 24, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Afsaneh Motamed Khorasani
Good Documentation and Record Keeping Best Practices (FDA & EMA)
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

Kelly Thomas Thursday, January 24, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Kelly Thomas
Establishing an Effective Change Control Program
This Change Control training course will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control system.

Dr. Robert North Thursday, January 24, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Robert North
Writing Effective Human Factors Validation Study Protocols for Efficient FDA Approval
Providing a clear, concise story of how you plan to conduct you human factors validation requires thorough coverage of a variety of topics.

Lamont M. Fulton Friday, January 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Lamont M. Fulton
QbD Development Process Evaluating Critical Steps
The topic of discussion focuses on practical and realistic approaches to implementation QbD, and how to apply QbD .

Dr. Shuguang Huang Friday, January 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:2 Hours
Price: ¤190.00
by: Dr. Shuguang Huang
2-Hour Virtual Seminar - Biomarker Development and Validation - A Statistical Perspective
Biomarker is very critical in pre-clinical drug discovery, clinical translational research, diagnostic product (including companion diagnostic) development. This webinar will focus on three areas:

Eyal Lerner Friday, January 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Eyal Lerner
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

Jeff Kasoff Friday, January 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Jeff Kasoff
Complaint Handling in Compliance with FDA and ISO Regulations
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.

Charles H. Paul Friday, January 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
Preventing Human Error in the Life Sciences
Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients.Human error is a frequent occurrence in pharmaceutical manufacturing.

Jason Teliszczak Friday, January 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Jason Teliszczak
Food Safety - Food Certifications - What Certification is Best for your Company?
Since the Food Safety Modernization Act of 2010 became live in 2011 and the Global Food Safety Initiative (GFSI) began gaining significant ground since 2012, certification is now key to gain and maintain clients as well as ensure compliance.

Carolyn Troiano Monday, January 28, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar on In-Depth Computer System Validation (CSV) for FDA Compliance
This 3-Hour webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, and You'll learn about the various computer system.

Wayne Taylor Monday, January 28, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Wayne Taylor
Validation Sampling Plans for Process Validation, Design Verification and CAPA Effectiveness Checks
This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:

Ms. Michael Redmond Tuesday, January 29, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Ms. Michael Redmond
Creating a Cyber Incident Response Program that Works
The best way forward is an efficient Incident Response Program that allows an organization to respond with speed and agility, while empowering businesses to maintain continuous operations. Such a solution also reduces revenue loss, reduces fines and lawsuits and protects brand reputation.

John E Lincoln Tuesday, January 29, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: John E Lincoln
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

Edwin Waldbusser Tuesday, January 29, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Edwin Waldbusser
Qualification of Contract Software Developers Based on Practical Experience
This webinar will explain the regulatory requirements and a risk-based procedure to qualify and manage suppliers that develop software for your company. The phases of the selection process, from compiling a list of candidate developers through the qualification audit and final decision, will be explained.

Mike Thomas Wednesday, January 30, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Mike Thomas
Excel as a BI Tool - Power Pivot and Power Query 101
Power Pivot and Power Query are free addins for Excel, written by Microsoft (in fact in Excel 2016 and later Power Query is built into the application and not an addin at all).

Jerry Lanese Wednesday, January 30, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Jerry Lanese
Laboratory Investigation of Out-of-Specification Results
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

Karl J Hemmerich Thursday, January 31, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Karl J Hemmerich
Validating Radiation Sterilization for Medical Products
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

Angela Bazigos Thursday, January 31, 2019
12:00 PM PST | 03:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Risk Based Incident Management and CAPA for GxP Computerized Systems Operations
This Webinar specifically addresses the Incident Management and CAPA processes of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant processes and procedures.

David Nettleton Thursday, January 31, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: David Nettleton
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

Roger Cowan Thursday, January 31, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: Roger Cowan
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Emil W Ciurczak Thursday, January 31, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Control-Analysis Instrumentation used in PAT and Continuous Manufacturing
We will briefly discuss how to go from minimum sampling, sending them to a lab, and waiting for results, to real-time monitoring, taking huge numbers of readings, and how to understand and apply these data to control and improve new and existing products.

Wayne Taylor Monday, February 4, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Wayne Taylor
Medical Devices - Complying With 820.250 Statistical Methods
Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for:

Robert J. Russell Monday, February 4, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Robert J. Russell
BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now
The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.

Michael Abitz Tuesday, February 5, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Michael Abitz
Fishbone Diagramming
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

John E Lincoln Tuesday, February 5, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: John E Lincoln
Dietary Supplements CGMPS - 21 CFR 111 Compliance
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

Casper Uldriks Tuesday, February 5, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
FDA's Problem with Software Monsters
Software's level of complexity and use keeps expanding at exponential levels. Likewise, the potential risks to health and loss of privacy follow suit. Ransomeware attacks hold software programs hostage until you pay the culprit thousands of dollars.

Tom Fragale Tuesday, February 5, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Tom Fragale
Microsoft Outlook Tips, Tricks, and Productivity Tools
This 60 minute Get Organized with Outlook session will encourage and enlightened Outlook users on how to use Microsoft Outlook to more confidently and efficiently organize their information and commitments.

Angela Bazigos Wednesday, February 6, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Lean Document Control for Manufacturing in Life Sciences
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

Ginette Collazo Wednesday, February 6, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Susanne Manz Wednesday, February 6, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Quality is not an Organization
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

John N. Zorich Wednesday, February 6, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: John N. Zorich
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Michael Esposito Wednesday, February 6, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Michael Esposito
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.

Dr. Afsaneh Motamed Khorasani Thursday, February 7, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Afsaneh Motamed Khorasani
Good Documentation Guideline (Chapter 1029 USP)
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials).

Joe Lynch Thursday, February 7, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Joe Lynch
Block Chain Made Easy - Introduction and Basics for Non-Techies
Once a block is written to the blockchain it can't be altered by anyone. If somebody tries to introduce a fake transaction into the ledger, he can only do so by adding it to all copies of distributed ledger (which is not possible, as every block is cryptographically linked with previous and next block) else that transaction is spotted and will be removed. Before a record is written to the blockchain, it needs to be verified and this is done by special nodes (computers) called miners.

Jeff Kasoff Friday, February 8, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Jeff Kasoff
Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.

Emil W Ciurczak Friday, February 8, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Pharmaceutical and Medical Applications of Near - Infrared Spectroscopy
The webinar will briefly review the theory and hardware available for near-infrared spectroscopy: how and why it is good for the applications chosen.

Jason Teliszczak Friday, February 8, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Jason Teliszczak
Food Safety - Food Defense
Since the Food Safety Modernization Act of 2010 was signed into law by President Obama on January 4, 2011, Food Defense is now clearly called out and must be adhered to.

David Ringstrom Monday, February 11, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: David Ringstrom
Master Excel: Transcend the VLOOKUP Function
Excel expert David Ringstrom, CPA, introduces several lookup functions, including VLOOKUP, HLOOKUP, MATCH, and CHOOSE, in this valuable presentation. These powerful Excel functions allow you to rapidly develop accurate spreadsheets and look up information, such as pay rates, item prices, and accounting results, versus manually linking to specific cells.

Teri C. Soli Tuesday, February 12, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Teri C. Soli
Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.

Dennis Taylor Tuesday, February 12, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dennis Taylor
Excel Formulas and Functions
Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Angela Bazigos Tuesday, February 12, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Audit Trail Generation and Review
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will learn the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

Kelly Thomas Tuesday, February 12, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Kelly Thomas
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture.

Dr. Ludwig Huber Wednesday, February 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Mike Thomas Wednesday, February 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Mike Thomas
Excel Automation - Automating Tasks with Macros
Do you find yourself repeatedly performing the same actions or tasks in your spreadsheets? Do you have a time-consuming Excel-based process that you want to automate?

Edwin Waldbusser Wednesday, February 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Edwin Waldbusser
Software Validation for the New FDA Inspections
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

Angela Bazigos Wednesday, February 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Off label Promotion of Drugs and Medical Devices - FDA's Latest
Off Label Promotion for Drugs and Medical Devices is a controversial topic which often puts FDA and industry at loggerheads. FDA continues to need to ensure public health by protect public health by ensuring that medical products distributed in the United States are safe and effective for their intended use while industry believes that safe and effective off label use is warranted. It is further complicated by today's patient who is much more savvy with regards to treatment and sometimes demands off-label use of products.

Ben Woodcock Wednesday, February 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Ben Woodcock
Human Machine Interface and Alarm Handling
The Human Machine Interface within a control room is the main (and in some cases only) interface and operator has with the rest of a system. Therefore, the HMI, is an operator's primary source of data.

Carolyn Troiano Thursday, February 14, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Current Trends in CyberSecurity Threats to Medical Devices
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

Derk Yntema Thursday, February 14, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Derk Yntema
3-Hour Virtual Seminar on GDPR - European Privacy Regulation what and how
The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

Charles H. Paul Thursday, February 14, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
FDA Audit Best Practices - Do's and Don'ts
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Jerry Lanese Friday, February 15, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Jerry Lanese
Analytical Method Validation
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

Lamont M. Fulton Friday, February 15, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Lamont M. Fulton
505(B)(2) APPLICATIONs; Standards for Approval
The submission of a 505(b)(2) applications must be based on the presentation of required scientific evidence of safety and equivalency studies, These studies should show sameness of active ingredients between the proposed drug and the RLD. Thus, there must be a careful evaluation of any and all differences:

Danielle DeLucy Friday, February 15, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Danielle DeLucy
Handling OOS Test Results and Completing Robust Investigations
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.

Robert J. Russell Friday, February 15, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Robert J. Russell
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Roger Cowan Monday, February 18, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Roger Cowan
Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.

David Nettleton Tuesday, February 19, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: David Nettleton
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR).

John E Lincoln Wednesday, February 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: John E Lincoln
Verification vs Validation-Product, Process or Equipment and QMS Software
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.

Angela Bazigos Wednesday, February 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
European Data Protection Regulation - Latest
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.

John N. Zorich Wednesday, February 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: John N. Zorich
Valid Statistical Rationales for Sample Sizes
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

John C. Fetzer Tuesday, February 21, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: John C. Fetzer
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.

Ginette Collazo Thursday, February 21, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Supervising a Human Error Free Environment: You can do a Lot More than you Think
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Salma Michor Thursday, February 21, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Salma Michor
The New EU Medical Device Regulation
Regulation proposals of the European Commission

Jeff Kasoff Friday, February 22, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Jeff Kasoff
Equipment Validation, Tracking, Calibration and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements.

Laura Brown Monday, February 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
Avoid Significant Fines - Ensure GDPR Compliance for Drug development and Clinical Trials?
The General Data Protection Regulation (GDPR) is new legislation that had come into force on 25th of May 2018 it has brought substantial changes to the rules around personal data and its use. While it builds on existing Data Protection legislation, it represents a significant change for organisations that hold and process personal data particularly for clinical trial data and drug development.

Edwin Waldbusser Tuesday, February 26, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Edwin Waldbusser
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This webinar details the regulation and how it applies to computerized systems.

Dennis Taylor Tuesday, February 26, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤190.00
by: Dennis Taylor
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

David Nettleton Tuesday, February 26, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: David Nettleton
How to validate software for SaaS-Cloud-Local Hosting
This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based approach to COTS software validation minimizes documentation and ensures efficient implementation of new and upgraded computer systems.

Dr. Ludwig Huber Wednesday, February 27, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Mike Thomas Wednesday, February 27, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Mike Thomas
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos. With an abundance of features and versions for desktop and mobile, there's really no excuse not to be organized. Or so the theory goes.

Joy McElroy Wednesday, February 27, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Joy McElroy
GLPs: How are they Associated with GMPs and SOPs
In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.

Angela Bazigos Wednesday, February 27, 2019
12:00 PM PST | 03:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Risk Based Service Management and Performance Monitoring for GxP Computerized Systems Operations
This Webinar specifically addresses the Service Management and Performance Monitoring of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant processes and procedures.

Susanne Manz Thursday, February 28, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Susanne Manz
3-Hour Virtual Seminar on CAPA for Medical Devices
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

Emil W Ciurczak Thursday, February 28, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Basic Design of Experiments
Traditional batch processing is time-consuming and expensive to perform. With intermediate steps being stored until the following step. A batch not only takes weeks to produce, but there is no control of the process under current GMP. To enhance the control (and the quality) of products, the USFDA issued several Guidances, covering PAT and QbD.

Danielle DeLucy Thursday, February 28, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

Kelly Thomas Thursday, February 28, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Kelly Thomas
Aseptic Processing Overview and Validation
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

Charles H. Paul Thursday, February 28, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
Achieving World Class Regulatory Compliance in the Life Sciences
This webinar will address each of the 7 keys to compliance excellence that form the foundation for any excellent organization. We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organization.

Angela Bazigos Monday, March 4, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Boot Camp on Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds
All methodologies described in this presentation are also used by FDA labs. FDA applies them to education, inspections, data collections, standard setting, investigation of outbreaks and enforcement actions.

Michael Abitz Tuesday, March 5, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Michael Abitz
Root Cause Failure Analysis Closed Loop Corrective Action
Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Steven Wachs Tuesday, March 5, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: Steven Wachs
Determining Sample Size: What Sample Size Should I Use?
The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.

John Chapman Wednesday, March 6, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: John Chapman
Verification vs. Validation in Regulated Industries
The meanings and regulatory requirements of the terms "verification"and "validation"are often confusing to engineers and even some regulatory professionals.

Susanne Manz Wednesday, March 6, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.

Dr. Ludwig Huber Thursday, March 7, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Jeff Kasoff Friday, March 8, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Jeff Kasoff
The FDA Inspection: Preparation, Management, and Follow - up
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics..

Danielle DeLucy Monday, March 11, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
Implementation and Management of GMP Data Integrity
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.

Angela Bazigos Monday, March 11, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's 21 CFR 11 Add-On Inspections - Recent Updates
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

Kelly Thomas Monday, March 11, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Kelly Thomas
Implementing a Robust Data Integrity Program
As regulators are focusing their inspection on data integrity, it is important that managers, supervisors and users in regulated GMP laboratories understand the issues relative to data integrity and implement robust programs to ensure compliance.

David Ringstrom Tuesday, March 12, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: David Ringstrom
Reclaiming Large Excel Spreadsheets
Working with large spreadsheets can slow users down in numerous ways. In addition, looking at too many numbers at once can lead to fatigue, increasing the chance of misinterpreting data or making spreadsheet errors.

Mike Thomas Tuesday, March 12, 2019
12:00 PM PST | 03:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Mike Thomas
OneNote 2016 - Bringing Order to your Digital Chaos
For many people the holy grail of organization is a world where email overload doesn't exist and where all those sticky notes and paper notepads are magically replaced by a digital paperless system. Using OneNote, a free application that you will find in the Microsoft Office suite, this dream can become a reality.

Michael Esposito Tuesday, March 12, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Michael Esposito
Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.

Laura Brown Tuesday, March 12, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
New GCP Compliance Requirements for Clinical QMS (Quality Management Systems)
Currently pharmaceutical and medical device industry guidance for quality in clinical development is fractured across multiple documents from multiple sources. Also, with the implementation of ICH GCP R2, it is expected that the CQMS should be risk-based.

Casper Uldriks Tuesday, March 12, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Casper Uldriks
3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

Edwin Waldbusser Wednesday, March 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Edwin Waldbusser
How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

John C. Fetzer Wednesday, March 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: John C. Fetzer
Analytical Method Validation Under Good Laboratory Practices - GLPs
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Ben Woodcock Wednesday, March 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Ben Woodcock
What is Human Factors and why is it Important?
This webinar is tailored to provide an overview of human factors and the benefits of applying human factors within the design process and ongoing system operations.

Angela Bazigos Thursday, March 14, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's Quality Metrics - Latest Advances
This presentation has been created directly from FDA material, using slides from FDA presentations, both internally to the FDA and to the industry at large. Comments from FDA and industry experts have been captured as well, to provide context and deeper understanding for the trainee.

Salma Michor Thursday, March 14, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Salma Michor
Combination Products Registration
During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.

Carolyn Troiano Friday, March 15, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Trends for Computer System Validation (CSV), Medical Device Compliance and FDA Enforcement
This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems.

Emil W Ciurczak Friday, March 15, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Theory and Practice of Near-Infrared Spectroscopy
NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with "commonly used" spectrometers, now in use and more familiar to analysts.

Angela Bazigos Wednesday, March 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Export Certificate for Medical Devices - Edge Out Your Competition!
Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply proof of the products' status as regulated by the FDA. An export certificate is a document prepared by FDA that has information about a product's regulatory or marketing status in the U.S.

John E Lincoln Wednesday, March 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: John E Lincoln
Device Changes, FDA Changes, and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Jeff Kasoff Friday, March 22, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Jeff Kasoff
FDA Inspections - Do's and Don'ts
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

Susanne Manz Monday, March 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Secrets to Writing Effective SOPs for Medical Device QMS
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

John Chapman Tuesday, March 26, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: John Chapman
FMEA & Risk Management for Medical Devices
FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management.

Dr. Ludwig Huber Wednesday, March 27, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤190.00
by: Dr. Ludwig Huber
2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

Carolyn Troiano Thursday, March 28, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Computer System Validation (CSV) for FDA-Regulated Computers
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

Angela Bazigos Friday, March 29, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Boot Camp on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.

Angela Bazigos Wednesday, April 3, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Audit Trail Generation and Review
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

Casper Uldriks Tuesday, April 9, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
FDA's New Import Program for 2019
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

Michael Esposito Wednesday, April 10, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Michael Esposito
Strategies To Prevent Manufacture And Distribution Of Substandard Medications
Substandard product can exist even if the product itself is manufactured according to quality standards. Muhammad H. Zaman, in his book Bitter Pills, recalls his visit to a warehouse in Ghana that had no climate control, with temperatures in the warehouse reaching 95 degrees Fahrenheit.

Casper Uldriks Tuesday, June 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
Responsibility for Off-label Claims in Social Media
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Casper Uldriks Tuesday, July 16, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Casper Uldriks
3-Hour Virtual Seminar on FDA Imports Require Precision in 2019
Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct, or else, FDA's entry requirements with detain your product. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.

Casper Uldriks Tuesday, August 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
FDA's New Import Program for 2019
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Miles Hutchinson
    How to Design and Implement Outstanding KPI Performance Dash
    Grab a cup of coffee and join us to learn how to improve your KPI focus, and juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Ensure your Performance Dashboards are crisp, attention grabbing and clearly identify significant performance trends. Know whether your business is meeting or exceeding its goals with your early warning system of leading and trailing performance indicators.

  • Susanne Manz Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Susanne Manz
    Secrets to Writing Effective SOPs for Medical Device QMS
    Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

  • Susanne Manz Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Susanne Manz
    Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
    This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.

  • John Chapman Recorded
    View Anytime
    Price: ¤190.00
    by: John Chapman
    FMEA & Risk Management for Medical Devices
    FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management.

  • Michael Esposito Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Michael Esposito
    Strategies To Prevent Manufacture And Distribution Of Substandard Medications
    Substandard product can exist even if the product itself is manufactured according to quality standards. Muhammad H. Zaman, in his book Bitter Pills, recalls his visit to a warehouse in Ghana that had no climate control, with temperatures in the warehouse reaching 95 degrees Fahrenheit.

  • Steven Wachs Recorded
    View Anytime
    Duration:75 Minutes
    Price: ¤190.00
    by: Steven Wachs
    Determining Sample Size: What Sample Size Should I Use?
    The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.

  • John Chapman Recorded
    View Anytime
    Price: ¤190.00
    by: John Chapman
    Verification vs. Validation in Regulated Industries
    The meanings and regulatory requirements of the terms "verification"and "validation"are often confusing to engineers and even some regulatory professionals.

  • Dennis Taylor Recorded
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    Price: ¤240.00
    by: Dennis Taylor
    2-Hour Virtual Seminar on Mastering Excel Pivot Tables
    You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

  • Laura Brown Recorded
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    Price: ¤190.00
    by: Laura Brown
    New GCP Compliance Requirements for Clinical QMS (Quality Management Systems)
    Currently pharmaceutical and medical device industry guidance for quality in clinical development is fractured across multiple documents from multiple sources. Also, with the implementation of ICH GCP R2, it is expected that the CQMS should be risk-based.

  • Michael Esposito Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Michael Esposito
    Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
    This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.

  • Edwin Waldbusser Recorded
    View Anytime
    Price: ¤190.00
    by: Edwin Waldbusser
    How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance
    This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

  • Danielle DeLucy Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Danielle DeLucy
    Implementation and Management of GMP Data Integrity
    In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.

  • Danielle DeLucy Recorded
    View Anytime
    Price: ¤190.00
    by: Danielle DeLucy
    Batch Record Review and Product Release
    Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

  • Danielle DeLucy Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Danielle DeLucy
    Handling OOS Test Results and Completing Robust Investigations
    This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.

  • Laura Brown Recorded
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    Price: ¤190.00
    by: Laura Brown
    Avoid Significant Fines - Ensure GDPR Compliance for Drug development and Clinical Trials?
    The General Data Protection Regulation (GDPR) is new legislation that had come into force on 25th of May 2018 it has brought substantial changes to the rules around personal data and its use. While it builds on existing Data Protection legislation, it represents a significant change for organisations that hold and process personal data particularly for clinical trial data and drug development.

  • Edwin Waldbusser Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Edwin Waldbusser
    21 CFR Part 11 - Compliance for Electronic Records and Signatures
    This webinar details the regulation and how it applies to computerized systems.

  • Edwin Waldbusser Recorded
    View Anytime
    Price: ¤190.00
    by: Edwin Waldbusser
    Software Validation for the New FDA Inspections
    This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

  • Salma Michor Recorded
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    Price: ¤190.00
    by: Salma Michor
    Combination Products Registration
    During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.

  • Salma Michor Recorded
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    Price: ¤190.00
    by: Salma Michor
    The New EU Medical Device Regulation
    Regulation proposals of the European Commission

  • John C. Fetzer Recorded
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    Price: ¤190.00
    by: John C. Fetzer
    Analytical Method Validation Under Good Laboratory Practices - GLPs
    If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

  • John C. Fetzer Recorded
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    Price: ¤190.00
    by: John C. Fetzer
    HPLC Analytical Method Development and Validation
    Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.

  • Carolyn Troiano Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Carolyn Troiano
    Computer System Validation (CSV) for FDA-Regulated Computers
    FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

  • Derk Yntema Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Derk Yntema
    3-Hour Virtual Seminar on GDPR - European Privacy Regulation what and how
    The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

  • Dr. Ludwig Huber Recorded
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    Duration:3 Hours
    Price: ¤240.00
    by: Dr. Ludwig Huber
    2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11
    FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

  • Dr. Ludwig Huber Recorded
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    Duration:75 Minutes
    Price: ¤190.00
    by: Dr. Ludwig Huber
    Understanding the USP Chapter 1224 for Transfer of Analytical Methods
    When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

  • Dr. Ludwig Huber Recorded
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    Duration:75 Minutes
    Price: ¤190.00
    by: Dr. Ludwig Huber
    Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
    Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

  • Dr. Ludwig Huber Recorded
    View Anytime
    Duration:75 Minutes
    Price: ¤190.00
    by: Dr. Ludwig Huber
    FDA's New Enforcement of 21 CFR Part 11
    FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

  • David Ringstrom Recorded
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    Price: ¤190.00
    by: David Ringstrom
    Reclaiming Large Excel Spreadsheets
    Working with large spreadsheets can slow users down in numerous ways. In addition, looking at too many numbers at once can lead to fatigue, increasing the chance of misinterpreting data or making spreadsheet errors.

  • David Ringstrom Recorded
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    Price: ¤190.00
    by: David Ringstrom
    Master Excel: Transcend the VLOOKUP Function
    Excel expert David Ringstrom, CPA, introduces several lookup functions, including VLOOKUP, HLOOKUP, MATCH, and CHOOSE, in this valuable presentation. These powerful Excel functions allow you to rapidly develop accurate spreadsheets and look up information, such as pay rates, item prices, and accounting results, versus manually linking to specific cells.

  • Joy McElroy Recorded
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    Price: ¤190.00
    by: Joy McElroy
    GLPs: How are they Associated with GMPs and SOPs
    In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.

  • Angela Bazigos Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Angela Bazigos
    Audit Trail Generation and Review
    This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

  • Angela Bazigos Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Angela Bazigos
    3-Hour Boot Camp on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
    This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.

  • Angela Bazigos Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Angela Bazigos
    Export Certificate for Medical Devices - Edge Out Your Competition!
    Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply proof of the products' status as regulated by the FDA. An export certificate is a document prepared by FDA that has information about a product's regulatory or marketing status in the U.S.

  • Angela Bazigos Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Angela Bazigos
    FDA's Quality Metrics - Latest Advances
    This presentation has been created directly from FDA material, using slides from FDA presentations, both internally to the FDA and to the industry at large. Comments from FDA and industry experts have been captured as well, to provide context and deeper understanding for the trainee.

  • Angela Bazigos Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Angela Bazigos
    3-Hour Boot Camp on Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds
    All methodologies described in this presentation are also used by FDA labs. FDA applies them to education, inspections, data collections, standard setting, investigation of outbreaks and enforcement actions.

  • Dennis Taylor Recorded
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    Price: ¤190.00
    by: Dennis Taylor
    Excel Formulas and Functions
    Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

  • Steven S. Kuwahara Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Steven S. Kuwahara
    GMP Expectations for Products Used in Early Phase IND Studies
    FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

  • Emil W Ciurczak Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Emil W Ciurczak
    Theory and Practice of Near-Infrared Spectroscopy
    NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with "commonly used" spectrometers, now in use and more familiar to analysts.

  • Emil W Ciurczak Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Emil W Ciurczak
    Basic Design of Experiments
    Traditional batch processing is time-consuming and expensive to perform. With intermediate steps being stored until the following step. A batch not only takes weeks to produce, but there is no control of the process under current GMP. To enhance the control (and the quality) of products, the USFDA issued several Guidances, covering PAT and QbD.

  • Emil W Ciurczak Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Emil W Ciurczak
    Pharmaceutical and Medical Applications of Near - Infrared Spectroscopy
    The webinar will briefly review the theory and hardware available for near-infrared spectroscopy: how and why it is good for the applications chosen.

  • Jerry Lanese Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Jerry Lanese
    Analytical Method Validation
    An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

  • Jerry Lanese Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Jerry Lanese
    Laboratory Investigation of Out-of-Specification Results
    The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

  • Emil W Ciurczak Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Emil W Ciurczak
    Control-Analysis Instrumentation used in PAT and Continuous Manufacturing
    We will briefly discuss how to go from minimum sampling, sending them to a lab, and waiting for results, to real-time monitoring, taking huge numbers of readings, and how to understand and apply these data to control and improve new and existing products.

  • Ms. Michael Redmond Recorded
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    Duration:60 Minutes
    Price: ¤190.00
    by: Ms. Michael Redmond
    Creating a Cyber Incident Response Program that Works
    The best way forward is an efficient Incident Response Program that allows an organization to respond with speed and agility, while empowering businesses to maintain continuous operations. Such a solution also reduces revenue loss, reduces fines and lawsuits and protects brand reputation.

  • Lamont M. Fulton Recorded
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    Price: ¤190.00
    by: Lamont M. Fulton
    505(B)(2) APPLICATIONs; Standards for Approval
    The submission of a 505(b)(2) applications must be based on the presentation of required scientific evidence of safety and equivalency studies, These studies should show sameness of active ingredients between the proposed drug and the RLD. Thus, there must be a careful evaluation of any and all differences:

  • Casper Uldriks Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Casper Uldriks
    FDA's New Import Program for 2019
    The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

  • Casper Uldriks Recorded
    View Anytime
    Duration:3 Hours
    Price: ¤340.00
    by: Casper Uldriks
    3-Hour Virtual Seminar on FDA Imports Require Precision in 2019
    Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct, or else, FDA's entry requirements with detain your product. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    Responsibility for Off-label Claims in Social Media
    FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    FDA's New Import Program for 2019
    The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

  • Casper Uldriks Recorded
    View Anytime
    Duration:3 Hours
    Price: ¤340.00
    by: Casper Uldriks
    3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
    FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

  • Casper Uldriks Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Casper Uldriks
    FDA's Problem with Software Monsters
    Software's level of complexity and use keeps expanding at exponential levels. Likewise, the potential risks to health and loss of privacy follow suit. Ransomeware attacks hold software programs hostage until you pay the culprit thousands of dollars.

  • Susanne Manz Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Susanne Manz
    3-Hour Virtual Seminar on CAPA for Medical Devices
    CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

  • Susanne Manz Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Susanne Manz
    Quality is not an Organization
    What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

  • Susanne Manz Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Susanne Manz
    Essentials of Validation - IQ, OQ, PQ
    Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.

  • Mark Brengelman Recorded
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    Price: ¤190.00
    by: Mark Brengelman
    Regulation of the Practice of Geology in the United States
    Today's educated professionals in the earth sciences function in a maze of different educational and training requirements, which vary from state to state and from profession to profession.

  • Kelly Thomas Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Kelly Thomas
    Implementing a Robust Data Integrity Program
    As regulators are focusing their inspection on data integrity, it is important that managers, supervisors and users in regulated GMP laboratories understand the issues relative to data integrity and implement robust programs to ensure compliance.

  • Kelly Thomas Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Kelly Thomas
    Aseptic Processing Overview and Validation
    This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

  • Kelly Thomas Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Kelly Thomas
    Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
    This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture.

  • Kelly Thomas Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Kelly Thomas
    Establishing an Effective Change Control Program
    This Change Control training course will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control system.

  • Edwin Waldbusser Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Edwin Waldbusser
    Qualification of Contract Software Developers Based on Practical Experience
    This webinar will explain the regulatory requirements and a risk-based procedure to qualify and manage suppliers that develop software for your company. The phases of the selection process, from compiling a list of candidate developers through the qualification audit and final decision, will be explained.

  • Jason Teliszczak Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Jason Teliszczak
    Food Safety - Food Defense
    Since the Food Safety Modernization Act of 2010 was signed into law by President Obama on January 4, 2011, Food Defense is now clearly called out and must be adhered to.

  • Jason Teliszczak Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Jason Teliszczak
    Food Safety - Food Certifications - What Certification is Best for your Company?
    Since the Food Safety Modernization Act of 2010 became live in 2011 and the Global Food Safety Initiative (GFSI) began gaining significant ground since 2012, certification is now key to gain and maintain clients as well as ensure compliance.

  • Charles H. Paul Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Charles H. Paul
    Achieving World Class Regulatory Compliance in the Life Sciences
    This webinar will address each of the 7 keys to compliance excellence that form the foundation for any excellent organization. We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organization.

  • Charles H. Paul Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Charles H. Paul
    FDA Audit Best Practices - Do's and Don'ts
    This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

  • Charles H. Paul Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Charles H. Paul
    Preventing Human Error in the Life Sciences
    Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients.Human error is a frequent occurrence in pharmaceutical manufacturing.

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freemarker.core.Dot._getAsTemplateModel(Dot.java:74) at freemarker.core.Expression.getAsTemplateModel(Expression.java:89) at freemarker.core.ListLiteral.getModelList(ListLiteral.java:125) at freemarker.core.MethodCall._getAsTemplateModel(MethodCall.java:89) at freemarker.core.Expression.getAsTemplateModel(Expression.java:89) at freemarker.core.ListLiteral.getModelList(ListLiteral.java:125) at freemarker.core.MethodCall._getAsTemplateModel(MethodCall.java:89) at freemarker.core.Expression.getAsTemplateModel(Expression.java:89) at freemarker.core.BuiltIn$if_existsBI._getAsTemplateModel(BuiltIn.java:687) at freemarker.core.Expression.getAsTemplateModel(Expression.java:89) at freemarker.core.Assignment.accept(Assignment.java:90) at freemarker.core.Environment.visit(Environment.java:209) at freemarker.core.MixedContent.accept(MixedContent.java:92) at freemarker.core.Environment.visit(Environment.java:209) at freemarker.core.IfBlock.accept(IfBlock.java:82) at freemarker.core.Environment.visit(Environment.java:209) at freemarker.core.MixedContent.accept(MixedContent.java:92) at freemarker.core.Environment.visit(Environment.java:209) at freemarker.core.IteratorBlock$Context.runLoop(IteratorBlock.java:167) at freemarker.core.Environment.visit(Environment.java:416) at freemarker.core.IteratorBlock.accept(IteratorBlock.java:102) at freemarker.core.Environment.visit(Environment.java:209) at freemarker.core.MixedContent.accept(MixedContent.java:92) at freemarker.core.Environment.visit(Environment.java:209) at freemarker.core.IfBlock.accept(IfBlock.java:82) at freemarker.core.Environment.visit(Environment.java:209) at freemarker.core.MixedContent.accept(MixedContent.java:92) at freemarker.core.Environment.visit(Environment.java:209) at freemarker.core.Environment.process(Environment.java:189) at org.ofbiz.base.util.template.FreeMarkerWorker.renderTemplate(FreeMarkerWorker.java:210) at org.ofbiz.widget.screen.HtmlWidget.renderHtmlTemplate(HtmlWidget.java:201) at org.ofbiz.widget.screen.HtmlWidget$HtmlTemplate.renderWidgetString(HtmlWidget.java:245) at org.ofbiz.widget.screen.HtmlWidget.renderWidgetString(HtmlWidget.java:107) at org.ofbiz.widget.screen.ModelScreenWidget$PlatformSpecific.renderWidgetString(ModelScreenWidget.java:976) at org.ofbiz.widget.screen.ModelScreenWidget.renderSubWidgetsString(ModelScreenWidget.java:138) at org.ofbiz.widget.screen.ModelScreenWidget$DecoratorSection.renderWidgetString(ModelScreenWidget.java:676) at org.ofbiz.widget.screen.ModelScreenWidget$SectionsRenderer.render(ModelScreenWidget.java:167) at org.ofbiz.widget.screen.ModelScreenWidget$DecoratorSectionInclude.renderWidgetString(ModelScreenWidget.java:706) at org.ofbiz.widget.screen.ModelScreenWidget.renderSubWidgetsString(ModelScreenWidget.java:138) at org.ofbiz.widget.screen.ModelScreenWidget$Container.renderWidgetString(ModelScreenWidget.java:292) at org.ofbiz.widget.screen.ModelScreenWidget.renderSubWidgetsString(ModelScreenWidget.java:138) at org.ofbiz.widget.screen.ModelScreenWidget$Container.renderWidgetString(ModelScreenWidget.java:292) at org.ofbiz.widget.screen.ModelScreenWidget.renderSubWidgetsString(ModelScreenWidget.java:138) at org.ofbiz.widget.screen.ModelScreenWidget$Container.renderWidgetString(ModelScreenWidget.java:292) at org.ofbiz.widget.screen.ModelScreenWidget.renderSubWidgetsString(ModelScreenWidget.java:138) at org.ofbiz.widget.screen.ModelScreenWidget$Section.renderWidgetString(ModelScreenWidget.java:227) at org.ofbiz.widget.screen.ModelScreen.renderScreenString(ModelScreen.java:393) at org.ofbiz.widget.screen.ModelScreenWidget$DecoratorScreen.renderWidgetString(ModelScreenWidget.java:646) at org.ofbiz.widget.screen.ModelScreenWidget.renderSubWidgetsString(ModelScreenWidget.java:138) at org.ofbiz.widget.screen.ModelScreenWidget$Section.renderWidgetString(ModelScreenWidget.java:227) at org.ofbiz.widget.screen.ModelScreen.renderScreenString(ModelScreen.java:393) at org.ofbiz.widget.screen.ScreenRenderer.render(ScreenRenderer.java:132) at org.ofbiz.widget.screen.ScreenRenderer.render(ScreenRenderer.java:92) at org.ofbiz.widget.screen.ScreenWidgetViewHandler.render(ScreenWidgetViewHandler.java:98) at org.ofbiz.webapp.control.RequestHandler.renderView(RequestHandler.java:812) at org.ofbiz.webapp.control.RequestHandler.doRequest(RequestHandler.java:533) at org.ofbiz.webapp.control.ControlServlet.doGet(ControlServlet.java:202) at javax.servlet.http.HttpServlet.service(HttpServlet.java:690) at javax.servlet.http.HttpServlet.service(HttpServlet.java:803) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:290) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:206) at org.ofbiz.webapp.control.ContextFilter.doFilter(ContextFilter.java:259) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:235) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:206) at org.apache.catalina.core.StandardWrapperValve.invoke(StandardWrapperValve.java:233) at org.apache.catalina.core.StandardContextValve.invoke(StandardContextValve.java:175) at org.apache.catalina.core.StandardHostValve.invoke(StandardHostValve.java:128) at org.apache.catalina.valves.ErrorReportValve.invoke(ErrorReportValve.java:102) at org.apache.catalina.core.StandardEngineValve.invoke(StandardEngineValve.java:109) at org.apache.catalina.valves.AccessLogValve.invoke(AccessLogValve.java:568) at org.ofbiz.catalina.container.CrossSubdomainSessionValve.invoke(CrossSubdomainSessionValve.java:62) at org.apache.catalina.connector.CoyoteAdapter.service(CoyoteAdapter.java:286) at org.apache.jk.server.JkCoyoteHandler.invoke(JkCoyoteHandler.java:190) at org.apache.jk.common.HandlerRequest.invoke(HandlerRequest.java:283) at org.apache.jk.common.ChannelSocket.invoke(ChannelSocket.java:767) at org.apache.jk.common.ChannelSocket.processConnection(ChannelSocket.java:697) at org.apache.jk.common.ChannelSocket$SocketConnection.runIt(ChannelSocket.java:889) at org.apache.tomcat.util.threads.ThreadPool$ControlRunnable.run(ThreadPool.java:690) at java.lang.Thread.run(Thread.java:745) Software Verification & Validation
    Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    Software Verification & Validation
    Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood.

  • Robert J. Russell Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Robert J. Russell
    Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
    This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

  • Robert J. Russell Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Robert J. Russell
    BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now
    The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.

  • Robert J. Russell Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Robert J. Russell
    3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
    This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

  • Robert J. Russell Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Robert J. Russell
    Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
    The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

  • Lamont M. Fulton Recorded
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    Duration:60 Minutes
    Price: ¤190.00
    by: Lamont M. Fulton
    QbD Development Process Evaluating Critical Steps
    The topic of discussion focuses on practical and realistic approaches to implementation QbD, and how to apply QbD .

  • Derk Yntema Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Derk Yntema
    GDPR - European Privacy Regulation what and how
    The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

  • Carolyn Troiano Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Carolyn Troiano
    Trends for Computer System Validation (CSV), Medical Device Compliance and FDA Enforcement
    This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems.

  • Carolyn Troiano Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Carolyn Troiano
    Current Trends in CyberSecurity Threats to Medical Devices
    This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

  • Carolyn Troiano Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Carolyn Troiano
    3-Hour Virtual Seminar on In-Depth Computer System Validation (CSV) for FDA Compliance
    This 3-Hour webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, and You'll learn about the various computer system.

  • Dr. Robert North Recorded
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    Price: ¤190.00
    by: Dr. Robert North
    Writing Effective Human Factors Validation Study Protocols for Efficient FDA Approval
    Providing a clear, concise story of how you plan to conduct you human factors validation requires thorough coverage of a variety of topics.

  • Roger Cowan Recorded
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    Price: ¤190.00
    by: Roger Cowan
    Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards
    Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.

  • Roger Cowan Recorded
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    Duration:75 Minutes
    Price: ¤190.00
    by: Roger Cowan
    HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
    Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

  • Peggy Berry Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Peggy Berry
    Complaint Handling
    The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

  • Michael Esposito Recorded
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    Price: ¤190.00
    by: Michael Esposito
    Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
    The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.

  • Michael Esposito Recorded
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    Price: ¤190.00
    by: Michael Esposito
    Packaging and Labelling in the Pharmaceutical Supply Chain
    Packaging and Labeling form a bridge between the conception of a product and its realization and distribution, and consequently occupy a critical position in the success or failure of any pharmaceutical product launch or revision. Decision-makers need at least a cursory knowledge of potential pitfalls to create contingencies, as it is easier and more cost-effective to change things earlier in process than later.

  • John N. Zorich Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: John N. Zorich
    Valid Statistical Rationales for Sample Sizes
    This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

  • John N. Zorich Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: John N. Zorich
    Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
    The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

  • John N. Zorich Recorded
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    Duration:2 Hours
    Price: ¤240.00
    by: John N. Zorich
    2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes
    This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

  • John N. Zorich Recorded
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    Price: ¤190.00
    by: John N. Zorich
    Process Validation: Statistical Justification for Sample Size and the Use of Only 3 Lots
    This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.

  • Dr. Afsaneh Motamed Khorasani Recorded
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    Price: ¤190.00
    by: Dr. Afsaneh Motamed Khorasani
    Good Documentation Guideline (Chapter 1029 USP)
    Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials).

  • Dr. Afsaneh Motamed Khorasani Recorded
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    Price: ¤190.00
    by: Dr. Afsaneh Motamed Khorasani
    Good Documentation and Record Keeping Best Practices (FDA & EMA)
    Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

  • Wayne Taylor Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Wayne Taylor
    Medical Devices - Complying With 820.250 Statistical Methods
    Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for:

  • Wayne Taylor Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Wayne Taylor
    Validation Sampling Plans for Process Validation, Design Verification and CAPA Effectiveness Checks
    This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:

  • Eyal Lerner Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Eyal Lerner
    The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
    Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

  • Dr. Shuguang Huang Recorded
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    Duration:2 Hours
    Price: ¤240.00
    by: Dr. Shuguang Huang
    2-Hour Virtual Seminar - Biomarker Development and Validation - A Statistical Perspective
    Biomarker is very critical in pre-clinical drug discovery, clinical translational research, diagnostic product (including companion diagnostic) development. This webinar will focus on three areas:

  • Thomas Bento Recorded
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    Price: ¤190.00
    by: Thomas Bento
    The Value of a Human Factors Program
    This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.

  • Ginette Collazo Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Ginette Collazo
    Controlling Human Error in the Manufacturing Floor
    Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

  • Ginette Collazo Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Ginette Collazo
    Tools for Human Error Reduction
    Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

  • Ginette Collazo Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Ginette Collazo
    Supervising a Human Error Free Environment: You can do a Lot More than you Think
    Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

  • Ben Woodcock Recorded
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    Price: ¤190.00
    by: Ben Woodcock
    What is Human Factors and why is it Important?
    This webinar is tailored to provide an overview of human factors and the benefits of applying human factors within the design process and ongoing system operations.

  • Ben Woodcock Recorded
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    Price: ¤190.00
    by: Ben Woodcock
    Human Machine Interface and Alarm Handling
    The Human Machine Interface within a control room is the main (and in some cases only) interface and operator has with the rest of a system. Therefore, the HMI, is an operator's primary source of data.

  • Ben Woodcock Recorded
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    Price: ¤190.00
    by: Ben Woodcock
    Why Humans Error and What We can do About it
    Every system has a goal. Some systems may have more than one. The purpose of each part of a system is to successfully execute its task or tasks in order to support achieving that system goal or goals.

  • Michael Abitz Recorded
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    Price: ¤190.00
    by: Michael Abitz
    Fishbone Diagramming
    Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

  • Michael Abitz Recorded
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    Price: ¤190.00
    by: Michael Abitz
    Root Cause Failure Analysis Closed Loop Corrective Action
    Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

  • Angela Bazigos Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Angela Bazigos
    3-Hour Virtual Seminar on Risk Based Service Management and Performance Monitoring for GxP Computerized Systems Operations
    This Webinar specifically addresses the Service Management and Performance Monitoring of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant processes and procedures.

  • Jeff Kasoff Recorded
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    Duration:60 Minutes
    Price: ¤190.00
    by: Jeff Kasoff
    FDA Inspections - Do's and Don'ts
    Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

  • Jeff Kasoff Recorded
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    Price: ¤190.00
    by: Jeff Kasoff
    The FDA Inspection: Preparation, Management, and Follow - up
    This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics..

  • Jeff Kasoff Recorded
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    Price: ¤190.00
    by: Jeff Kasoff
    Equipment Validation, Tracking, Calibration and Preventive Maintenance
    FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements.

  • Jeff Kasoff Recorded
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    Price: ¤190.00
    by: Jeff Kasoff
    Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
    A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.

  • Jeff Kasoff Recorded
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    Price: ¤190.00
    by: Jeff Kasoff
    Complaint Handling in Compliance with FDA and ISO Regulations
    Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.

  • Jeff Kasoff Recorded
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    Price: ¤190.00
    by: Jeff Kasoff
    How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare
    Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

  • John E Lincoln Recorded
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    Price: ¤190.00
    by: John E Lincoln
    Device Changes, FDA Changes, and the 510(k)
    The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

  • John E Lincoln Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: John E Lincoln
    Verification vs Validation-Product, Process or Equipment and QMS Software
    The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.

  • John E Lincoln Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: John E Lincoln
    Dietary Supplements CGMPS - 21 CFR 111 Compliance
    21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

  • John E Lincoln Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: John E Lincoln
    3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
    FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

  • John E Lincoln Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: John E Lincoln
    Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements
    It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

  • Mike Thomas Recorded
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    Price: ¤190.00
    by: Mike Thomas
    OneNote 2016 - Bringing Order to your Digital Chaos
    For many people the holy grail of organization is a world where email overload doesn't exist and where all those sticky notes and paper notepads are magically replaced by a digital paperless system. Using OneNote, a free application that you will find in the Microsoft Office suite, this dream can become a reality.

  • Mike Thomas Recorded
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    Price: ¤190.00
    by: Mike Thomas
    Outlook - Master your Mailbox - Inbox Hero Inbox Zero
    For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos. With an abundance of features and versions for desktop and mobile, there's really no excuse not to be organized. Or so the theory goes.

  • Mike Thomas Recorded
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    Price: ¤190.00
    by: Mike Thomas
    Excel Automation - Automating Tasks with Macros
    Do you find yourself repeatedly performing the same actions or tasks in your spreadsheets? Do you have a time-consuming Excel-based process that you want to automate?

  • Mike Thomas Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Mike Thomas
    Excel as a BI Tool - Power Pivot and Power Query 101
    Power Pivot and Power Query are free addins for Excel, written by Microsoft (in fact in Excel 2016 and later Power Query is built into the application and not an addin at all).

  • Mike Thomas Recorded
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    Price: ¤190.00
    by: Mike Thomas
    Excel Formulas and Functions 101
    Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.

  • Dennis Taylor Recorded
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    Price: ¤190.00
    by: Dennis Taylor
    Time-Saving Excel Tips, Tricks and 100 Shortcuts
    Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

  • Dennis Taylor Recorded
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    Price: ¤190.00
    by: Dennis Taylor
    Mastering Excel Pivot Tables
    PivotTable capabilities are enormous; among its many tools and features.

  • Teri C. Soli Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Teri C. Soli
    Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
    Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.

  • Teri C. Soli Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Teri C. Soli
    Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
    It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

  • Angela Bazigos Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Angela Bazigos
    3-Hour Virtual Seminar on Risk Based Incident Management and CAPA for GxP Computerized Systems Operations
    This Webinar specifically addresses the Incident Management and CAPA processes of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant processes and procedures.

  • Tom Fragale Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Tom Fragale
    Microsoft Outlook Tips, Tricks, and Productivity Tools
    This 60 minute Get Organized with Outlook session will encourage and enlightened Outlook users on how to use Microsoft Outlook to more confidently and efficiently organize their information and commitments.

  • Tom Fragale Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Tom Fragale
    Going from Raw Data to Great Results with Excel PowerPivot and PowerQuery
    If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources. Luckily there are two Microsoft tools- PowerPivot and PowerQuery-that solve ALL of these issues, right inside Excel.

  • Angela Bazigos Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Angela Bazigos
    European Data Protection Regulation - Latest
    On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.

  • Angela Bazigos Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Angela Bazigos
    3-Hour Virtual Seminar on Off label Promotion of Drugs and Medical Devices - FDA's Latest
    Off Label Promotion for Drugs and Medical Devices is a controversial topic which often puts FDA and industry at loggerheads. FDA continues to need to ensure public health by protect public health by ensuring that medical products distributed in the United States are safe and effective for their intended use while industry believes that safe and effective off label use is warranted. It is further complicated by today's patient who is much more savvy with regards to treatment and sometimes demands off-label use of products.

  • Angela Bazigos Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Angela Bazigos
    Lean Document Control for Manufacturing in Life Sciences
    This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

  • Angela Bazigos Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Angela Bazigos
    If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
    Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

  • Angela Bazigos Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Angela Bazigos
    Audit Trail Generation and Review
    This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will learn the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

  • Charles H. Paul Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Charles H. Paul
    3-Hour Virtual Seminar on Project Management for Non-Project Managers
    This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

  • Casper Uldriks Recorded
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    Price: ¤190.00
    by: Casper Uldriks
    FDA's New Import Program for 2018
    The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

  • David Nettleton Recorded
    View Anytime
    Duration:75 Minutes
    Price: ¤190.00
    by: David Nettleton
    Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
    This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

  • Danielle DeLucy Recorded
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    Price: ¤190.00
    by: Danielle DeLucy
    Batch Record Review and Product Release
    Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

  • Joe Lynch Recorded
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    Duration:60 Minutes
    Price: ¤190.00
    by: Joe Lynch
    Block Chain Transformation: Understanding the Impacts and Applications in the Logistics Industry
    The logistics industry is huge, worldwide and critical to our global economy. The industry consists of transportation, warehousing, logistics and technology companies that move goods (physical assets) from producers to consumers.

  • Joe Lynch Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Joe Lynch
    Block Chain Made Easy - Introduction and Basics for Non-Techies
    Once a block is written to the blockchain it can't be altered by anyone. If somebody tries to introduce a fake transaction into the ledger, he can only do so by adding it to all copies of distributed ledger (which is not possible, as every block is cryptographically linked with previous and next block) else that transaction is spotted and will be removed. Before a record is written to the blockchain, it needs to be verified and this is done by special nodes (computers) called miners.

  • John N. Zorich Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: John N. Zorich
    Valid Statistical Rationales for Sample Sizes
    This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

  • Angela Bazigos Recorded
    View Anytime
    Duration:3 Hours
    Price: ¤340.00
    by: Angela Bazigos
    3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking
    This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.

  • Angela Bazigos Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Angela Bazigos
    Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
    This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

  • John N. Zorich Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: John N. Zorich
    Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
    The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

  • John N. Zorich Recorded
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    Duration:2 Hours
    Price: ¤240.00
    by: John N. Zorich
    2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes
    This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

  • Karl J Hemmerich Recorded
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    Price: ¤190.00
    by: Karl J Hemmerich
    Validating Radiation Sterilization for Medical Products
    Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

  • Karl J Hemmerich Recorded
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    Price: ¤190.00
    by: Karl J Hemmerich
    Accelerated Aging Techniques for Medical Device Packaging
    Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.

  • Dr. Ludwig Huber Recorded
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    Duration:75 Minutes
    Price: ¤190.00
    by: Dr. Ludwig Huber
    FDA's New Enforcement of 21 CFR Part 11
    FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

  • Dr. Ludwig Huber Recorded
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    Duration:75 Minutes
    Price: ¤190.00
    by: Dr. Ludwig Huber
    Validation of Analytical Methods and Procedures
    Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

  • Jerry Lanese Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Jerry Lanese
    Analytical Method Validation
    An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

  • Dr. Shuguang Huang Recorded
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    Duration:2 Hours
    Price: ¤240.00
    by: Dr. Shuguang Huang
    2-Hour Virtual Seminar - Biomarker Development and Validation - A Statistical Perspective
    Biomarker is very critical in pre-clinical drug discovery, clinical translational research, diagnostic product (including companion diagnostic) development. This webinar will focus on three areas:

  • Dr. Ludwig Huber Recorded
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    Duration:75 Minutes
    Price: ¤190.00
    by: Dr. Ludwig Huber
    Understanding the USP Chapter 1224 for Transfer of Analytical Methods
    When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

  • Dr. Ludwig Huber Recorded
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    Duration:75 Minutes
    Price: ¤190.00
    by: Dr. Ludwig Huber
    Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
    Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

  • Dennis Taylor Recorded
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    Price: ¤190.00
    by: Dennis Taylor
    Excel Formulas and Functions
    Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

  • Dennis Taylor Recorded
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    Duration:2 Hours
    Price: ¤240.00
    by: Dennis Taylor
    2-Hour Virtual Seminar on Mastering Excel Pivot Tables
    You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities:

  • Laura Brown Recorded
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    Price: ¤190.00
    by: Laura Brown
    EU General Data Protection Regulation (GDPR): Compliance for Drug development and Clinical Trials?
    The General Data Protection Regulation (GDPR) is new legislation that had come into force on 25th of May 2018 brings substantial changes to the rules around personal data and its use. While it aims at building on existing Data Protection legislation, it represents a significant change for organisations that hold and process personal data particularly for clinical trial data and drug development.

  • Dennis Taylor Recorded
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    Price: ¤190.00
    by: Dennis Taylor
    Time-Saving Excel Tips, Tricks and 100 Shortcuts
    Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

  • Dennis Taylor Recorded
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    Price: ¤190.00
    by: Dennis Taylor
    Mastering Excel Pivot Tables
    PivotTable capabilities are enormous; among its many tools and features.

  • Laura Brown Recorded
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    Price: ¤190.00
    by: Laura Brown
    How to Write SOPs which are Compliant for Inspections for a GXP Compliance
    This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.

  • John N. Zorich Recorded
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    Duration:60 Minutes
    Price: ¤190.00
    by: John N. Zorich
    Process Validation: Statistical Justification for Sample Size and the Use of Only 3 Lots
    This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.

  • John E Lincoln Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: John E Lincoln
    3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
    FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

  • John E Lincoln Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: John E Lincoln
    3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements
    This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

  • Wayne Taylor Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Wayne Taylor
    Validation Sampling Plans for Process Validation, Design Verification and CAPA Effectiveness Checks
    This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:

  • Wayne Taylor Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Wayne Taylor
    Medical Devices - Complying With 820.250 Statistical Methods
    Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for:

  • Angela Bazigos Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Angela Bazigos
    3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking
    This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.

  • Angela Bazigos Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Angela Bazigos
    How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements
    This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

  • Angela Bazigos Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Angela Bazigos
    FDA's 21 CFR 11 Add-On Inspections - Recent Updates
    In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

  • Angela Bazigos Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Angela Bazigos
    European Data Protection Regulation - 2018 Implementation
    On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.

  • Emil W Ciurczak Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Emil W Ciurczak
    Control-Analysis Instrumentation used in PAT and Continuous Manufacturing
    We will briefly discuss how to go from minimum sampling, sending them to a lab, and waiting for results, to real-time monitoring, taking huge numbers of readings, and how to understand and apply these data to control and improve new and existing products.

  • Dr. Afsaneh Motamed Khorasani Recorded
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    Price: ¤190.00
    by: Dr. Afsaneh Motamed Khorasani
    Good Documentation and Record Keeping Best Practices (FDA & EMA)
    Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

  • Dr. Ludwig Huber Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Dr. Ludwig Huber
    3-Hour Virtual Seminar on Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA-EMA, USP and ICH
    The 3-hour virtual seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement even most critical requirements.

  • Danielle DeLucy Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Danielle DeLucy
    Handling OOS Test Results and Completing Robust Investigations
    This training program will describe when a full investigation should be triggered and the frequency for re-testing and re-sampling. Attendees will also learn how to implement corrective and preventive action plans (CAPA).

  • Danielle DeLucy Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Danielle DeLucy
    Implementation and Management of GMP Data Integrity
    Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.

  • Dr. Afsaneh Motamed Khorasani Recorded
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    Price: ¤190.00
    by: Dr. Afsaneh Motamed Khorasani
    Good Documentation Guideline (Chapter 1029 USP)
    Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.

  • Susanne Manz Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Susanne Manz
    Risk Management Techniques for Medical Devices
    Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

  • Susanne Manz Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Susanne Manz
    Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
    This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.

  • Susanne Manz Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Susanne Manz
    Essentials of Validation - IQ, OQ, PQ
    Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management

  • Susanne Manz Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Susanne Manz
    Secrets to Writing Effective SOPs for Medical Device QMS
    Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

  • Susanne Manz Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Susanne Manz
    Death By CAPA - Does your CAPA Program Need a CAPA?
    This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.

  • Robert J. Russell Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Robert J. Russell
    BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now
    The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.

  • Angela Bazigos Recorded
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    Duration:3 Hours
    Price: ¤340.00
    by: Angela Bazigos
    3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
    Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.

  • Robert J. Russell Recorded
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    Duration:90 Minutes
    Price: