Webinar Search Results : 117 Upcoming webinars found.
Angela Bazigos Friday, August 17, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Writing Effective SOPs
Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?

Charles H. Paul Friday, August 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
Project Management for Non-Project Managers - Building the Work Breakdown Structure
The single most important aspect of any project is the defining of all the tasks that must be performed to accomplish the project's objectives.This definition is called the work breakdown structure.

Thomas Bento Friday, August 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Thomas Bento
Validation of Non-Product Software
This course will teach how to comply to 21 CFR Part 820.70(i) and effectively implement a software validation program for medical devices, meeting the FDA requirements and produce a safe product. We will explain the role of Risk Management in Non-Product Validation. How software requirements are used in validation will be described.

Robert J. Russell Friday, August 17, 2018
12:00 PM PDT | 03:00 PM EDT
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.

Dennis Taylor Friday, August 17, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Angela Bazigos Monday, August 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Project Management for Computer Systems Validation and 21 CFR 11 - Annex 11
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company's product.

Marina Malikova Monday, August 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Marina Malikova
FDA Regulation of Human Cells,Tissues and Cellular and Tissue-Based Products (HCT-Ps)
This course offers extensive examination of the FDA's regulations of biological products such as HCT/Ps from pre-clinical testing to post-marketing regulatory requirements. Specific ethical and regulatory considerations will be discussed for various HCT/Ps. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products.

Casper Uldriks Tuesday, August 21, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 hours
Price: ¤290.00
by: Casper Uldriks
3-Hour Virtual Seminar: FDA Imports Require Precision in 2018
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.

Angela Bazigos Tuesday, August 21, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on How the FDA are Trained for Medical Device Inspections
This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms.It will present the specific guidance FDA inspectors receive for each of the regulations.

Susanne Manz Wednesday, August 22, 2018
10:00 AM PDT | 01:00 PM EDT
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. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.

Ron Rael Thursday, August 23, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ron Rael
Strategic Management of Corporate Governance: Setting the Right Tone at the Top about Risk, Part 1
What is a risky decision? How do you size up a risk's impact? How do you hold reckless risk-takers accountable?

Angela Bazigos Thursday, August 23, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Eyal Lerner Friday, August 24, 2018
10:00 AM PDT | 01:00 PM EDT
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).

Tom Fragale Friday, August 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Tom Fragale
Managing Excel Lists and Databases: Time-Saving Shortcuts for Sorting, Filtering, Analyzing and More
Microsoft Excel has become the de facto spreadsheet application for business. But do you sometimes feel like you have rows and rows of data and it's hard to make heads or tails of it? This class will help you learn how to manage databases in Excel, and get the most out of them.

Sheldon Primus Friday, August 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Sheldon Primus
Behavior Based Safety System: A Guide to Building a Safety Culture
The Behavioral Based Safety system (BBS) is a valued tool used in conjunction with other safety and health aids, such as, job hazard analysis, fault tree analysis, audits, and inspections. The BBS focuses on the behavior of the worker which is measurable and observable, unlike a person's attitude.

Angela Bazigos Friday, August 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Implement Good Clinical Practices for Successful FDA and International Regulatory Authority Inspections
This webinar will highlight the salient points of Good Clinical Practice and will enable the participants to understand how to implement GCP to achieve clinical trial best practices, best patient safety and/or successful FDA and international regulatory authority inspections.

Danielle DeLucy Friday, August 24, 2018
11:30 AM PDT | 02:30 PM EDT
Duration:60 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. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Carolyn Troiano Monday, August 27, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Laura Brown Monday, August 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials - are you Ready for Implementation for May 25th 2018?
Attain an understanding of the General Data Protection Regulation (GDPR).Be able to understand the key of the main tenets of GDPR which impact on clinical trials.

Angela Bazigos Tuesday, August 28, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Export Certificate for Medical Devices - Edge Out Your Competition!
In today's global environment, sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the issues involved in managing regulations across different countries. To this end, certain countries require an Export Certificate that the manufacturer and its devices are indeed in compliance with FDA regulations.

Dennis Taylor Tuesday, August 28, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:2 Hours
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:

Casper Uldriks Tuesday, August 28, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
FDA's Revolutionary Change in Software Regulation
Congress recognized that FDA struggles with software regulation. So, Congress removed some software out of FDA's jurisdiction. Now FDA must revise its premarket and postmarket software regulatory approach, including mobile apps. Using voluntary standards in premarket submissions can be used more effectively. Even more dramatic, FDA's new Digital Health initiative turns FDA's premarket clearance program on its head.

Jerry Lanese Wednesday, August 29, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Lynn Fountain Wednesday, August 29, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
COSO New Fraud Principals
This course delves further into the expectations of COSO Principle Eight.We discuss and evaluate the COSO anti-fraud guide released in September 2016 and evaluate how the Fraud principles relate to the COSO 2013 principles.We also examine actions that organizations, management, and employees should be aware of in relationship to fraud.

Dr. Ludwig Huber Thursday, August 30, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Dr. Ludwig Huber
3-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.

Susanne Manz Thursday, August 30, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Preparing for an FDA Inspection - What you Need to Know
Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively.

Angela Bazigos Thursday, August 30, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
MDUFA IV - An Introduction
In this webinar,the speaker will review the background of the user fee legislation for medical devices.

Ginette Collazo Thursday, August 30, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Charles H. Paul Friday, August 31, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
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.

Susanne Manz Friday, August 31, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Susanne Manz
3-Hour Virtual Seminar on Design Controls for Medical Devices
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.

Casper Uldriks Friday, August 31, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
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.

Lamont M. Fulton Friday, August 31, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Lamont M. Fulton
Preparing for Pre and Post Approval Inspections
Agencies that monitor and regulate pharmaceutical product for human and animal use must review incumbent applications per required ICH GUIDLENES .However the information contained in the submitted applications should be verified by the authorities before approval is granted. Verification is accomplished through audit or inspection conducted by regulatory Pre-and post approval inspection process employed by various regulatory authority compliance units are particular to the ICH region.

Yingying Liu Friday, August 31, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Yingying Liu
Pharmaceutical Drug Registration in China
Bringing pharmaceutical products to market in China has become much easier for foreign companies. The Chinese FDA (CFDA), now renamed as CNDA, recently made a series of significant changes to the marketing authorisation regulations by issuing a large number of guidelines and opinions (in Chinese).

Tim Lombardo Friday, August 31, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Tim Lombardo
Game of Zones: a Practical Application of FDA Guidance Document - Control of Listeria Monocytogenes in Ready-to-Eat Foods
This webinar will break down recommendations included in the guidance document and provide some practical solutions to each.

Ginette Collazo Wednesday, September 5, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Ginette Collazo
3-Hour Virtual Seminar on How to Implement an Effective Human Error Investigation Program
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be 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.

John N. Zorich Wednesday, September 5, 2018
09:00 AM PDT | 12:00 PM EDT
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.

Laura Brown Wednesday, September 5, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:2 Hours
Price: ¤190.00
by: Laura Brown
2-Hour Virtual Seminar on How to comply with ICH GCP 2 Addendum
This informative session will cover these new requirements for auditing clinical trials, evaluate the changes and understand how these impact on auditors.

Marina Malikova Thursday, September 6, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Marina Malikova
Strategies to Mitigate Fiscal Risks in Clinical Trials: Coverage Analysis, Budgeting and Billing Compliance
This session is focused on processes and approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials. The ability to develop robust budgets, ensure billing compliance and adherence to CMS regulations for clinical trials remains a challenge for many clinical sites, sponsors and contract research organizations (CROs).

Robert J. Russell Thursday, September 6, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Robert J. Russell
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Susanne Manz Thursday, September 6, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
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.

Vanessa Lopez Thursday, September 6, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:2 Hours
Price: ¤190.00
by: Vanessa Lopez
2-Hour Virtual Seminar on Supplier and Service Provider Controls: FDA Expectations
This webinar will provide the regulatory requirements (US) of 21 CFR Section 820.50 (Purchasing Control) for the Medical Device industry and provide you with examples. It will furnish details on what should your Purchasing/Supplier Control management system address.

Shep Bentley Friday, September 7, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Shep Bentley
Obscure But Effective Regulatory Pathways for Devices
The entire world today engages regulations, whether these are by means of their own national laws, standards or requirements or else by means of borrowing the regulations of other nations that are deemed acceptable in their own right, in order to allow a medical device manufacturer to introduce a product into any market.

Angela Bazigos Friday, September 7, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Engaging with the FDA During New Drug Development
Why is it important to engage with the FDA?

Derk Yntema Friday, September 7, 2018
10:00 AM PDT | 01:00 PM EDT
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.

David Nettleton Monday, September 10, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Michael Esposito Monday, September 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 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.

Edwin Waldbusser Monday, September 10, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Shib Mookherjea Monday, September 10, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Shib Mookherjea
3-Hour Virtual Seminar on Highlights of FDA GLP Regulations and the Roles and Responsibilities in a GLP Facility
This 3 hour GLP virtual seminar will discuss various GLP regulations (FDA/OECD GLP's) along with highlighting roles and responsibilities of management and key personnel involved in drug development, safety & toxicity evaluation and QAU function in GLP testing facilities.

Mike Thomas Tuesday, September 11, 2018
12:00 PM PDT | 03:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Mike Thomas
Mastering Excel Formulas and Functions
Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job.

Angela Bazigos Tuesday, September 11, 2018
08:00 AM PDT | 11:00 PM EDT
Duration:3 Hours
Price: ¤290.00
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.

Lynn Fountain Tuesday, September 11, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Managing and Examining Travel and Entertainment Expense
This course provides insight on how to bring control and intelligent management to your company's T&E process.We evaluate how to bring people, process, technology, strategy and information together to provide the proper level of internal controls over expenditures.We also discuss the critical role of information technology and its utilization in today's cyber world and how that impacts travel and entertainment.

Carolyn Troiano Tuesday, September 11, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Medical Device Cybersecurity -Improving Compliance and your Company's Bottom Line
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. Cybersecurity is a serious concern for medical device safety and effectiveness. Without protection, software running on a medical device could cause severe injury or death to a patient.

Robert J. Russell Tuesday, September 11, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 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 Wednesday, September 12, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Roger Cowan
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
Control of suppliers such as Contract Manufacturing Organizations (CMO) has always been a requirement of the FDA and EU. With the issuance of these new regulatory documents the expectation is that there will be a written documentation of this control. Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement which is specific to a particular CMO. This webinar will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory perspective.

Laura Brown Wednesday, September 12, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
Compliance for Risk Based Approaches for Clinical Trials
FDA and EMA have communicated their expectations for trial oversight/ monitoring, monitoring systems, and investigative site oversight. These are described in the FDA Guidance Oversight of Clinical Investigations: A Risk- Based Approach to Monitoring and the EMA Reflection Paper on risk-based quality management in clinical trials both of which will be reviewed in this web seminar.

John N. Zorich Wednesday, September 12, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Charles H. Paul Wednesday, September 12, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
Preventing Human Error in the Life Sciences
This webinar will describe the nature of human error in terms of how it is manifest and it distinct properties. As human error is directly related to human performance, we must discuss the contribution human performance has upon the inherent error that is performed by workers in life science settings.

Rita Hoffman Thursday, September 13, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Rita Hoffman
Mastering the Art of Compliant Handling Challenges for Medical Device
Manufacturers of any class of medical devices are NEVER exempted from the Quality System regulation complaint requirements (820.198) or the general record requirements (820.180) which permit FDA review and copying of these records. Medical Device firms and Designated Agents for foreign firms don't understand the entire realm of the complaint process. Learn what it takes to stay in compliance and avoid risk to your products being removed from the market once you have received your PMA or 510(k).

Lauren Neighbours Thursday, September 13, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lauren Neighbours
US Regulatory Submissions and Publishing 101: Keys to Success
Effective regulatory strategy, like product design, requires "quality-by-design" approach and planning throughout the product development lifecycle. For pharmaceutical, device, and biotechnology companies, understanding how to effectively design and manage a regulatory submission can lead to a more efficient application development process and greatly increase the likelihood of marketing authorization.

Eleonora Babayants Friday, September 14, 2018
07:00 AM PDT | 10:00 AM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eleonora Babayants
Governance and Risk Control According to GxP-GMP Requirements
GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics.

Shep Bentley Friday, September 14, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Shep Bentley
Quality Agreements Made Easy
The requirements for the assurance of quality within networks and circles of entities whose responsibilities are increasing specialized present an especially vexing challenge to the managements of each of these organizations. The specification developer must be aware of the capabilities of the contract manufacturer and the contract manufacturer must be aware of the limitations of the specification developer, for example.

Jerry Lanese Friday, September 14, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Jerry Lanese
cGMPs in the Quality Control Laboratory
Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations.

Angela Bazigos Tuesday, September 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
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. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Danielle DeLucy Wednesday, September 19, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Tom Parke Thursday, September 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Tom Parke
Clinical Trial Simulation Guided Trial Design
Clinical trial simulation (in this context) is the software simulation of a clinical trial to evaluate the performance of a proposed statistical design.

Dr. Ludwig Huber Thursday, September 20, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Dr. Afsaneh Motamed Khorasani Friday, September 21, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Dr. Afsaneh Motamed Khorasani
How to Prepare a Standard Operating Procedure (SOP)
Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit.

Eleonora Babayants Friday, September 21, 2018
07:00 AM PDT | 10:00 AM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eleonora Babayants
Data Integrity in Compliance with GXP-GMP Regulations
There are GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements.

Yingying Liu Friday, September 21, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Yingying Liu
Clinical Trial Applications in China
China FDA (CFDA), now renamed as CNDA, made a series of significant changes to the clinical trial regulations, issuing a large number of guidelines and opinions in Chinese.

Carolyn Troiano Monday, September 24, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3- Hour Virtual Seminar 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.

David Nettleton Monday, September 24, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: David Nettleton
3-Hour Virtual Seminar on Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar details the regulation and how it applies to computerized systems.

Amer Alghabban Monday, September 24, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Amer Alghabban
3-Hour Virtual Seminar the Do's and Don'ts Before, During, and After an FDA GCP Inspection
Good Clinical Practice (GCP) inspection by the US Food and Drug Administration (FDA) can lead to the detection of problems with the conduct of your clinical trial. FDA requirements regarding GCP and related inspections have been around for decades.

Ginette Collazo Tuesday, September 25, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Charles H. Paul Tuesday, September 25, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
Implementing Effective CAPA Systems
How CAPA's are executed and managed is crucial to maintaining a compliant organization. Inadequate CAPA processes continue to be a major GMP deficiency and consistently make the FDA's top five list for adverse observations.

Lynn Fountain Wednesday, September 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Critical Concepts to Understand the Balance Sheet, Income Statement, Cash Flow and Retained Earnings
Rather than focus on the computations and tactics of each of the statements, this training program will cover the important concepts of how the statements interact and relate to each other providing management with the critical information needed to manage financial stability of their organization.

Angela Bazigos Wednesday, September 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's enforcement of 21 CFR part 11 compliance
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

Angela Bazigos Thursday, September 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Excel Spreadsheets for 21 CFR 11 Compliance
Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

Dr. Ludwig Huber Thursday, September 27, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
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.

Roger Cowan Friday, September 28, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Roger Cowan
HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. 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. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product.

Tom Fragale Friday, September 28, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Tom Fragale
PowerPoint Tips and Tricks
Even in today's online world, live, face-to-face presentations are still so crucial. That includes presentations of all types: training, sales, staff meetings, stock holder summaries, new company policies, church or organization meetings, fundraisers, etc. Microsoft PowerPoint is still the gold-standard of presentation tools. Because it comes with Microsoft Office and Office 365, most computers have access to the program. But you still have to learn how to use this powerful program the proper way.

Edwin Waldbusser Tuesday, October 2, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Edwin Waldbusser
Medical Device Hazard Analysis Following ISO 14971
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools.

Susanne Manz Thursday, October 4, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Robert J. Russell Tuesday, October 9, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Robert J. Russell
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.

Charles H. Paul Tuesday, October 9, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
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.

Lynn Fountain Wednesday, October 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Complying with the Revenue Recognition Standard
This FASB revenue recognition standard webinar will discuss the various steps involved in this standard and also the technical guidance to prepare a revenue recognition model.

Danielle DeLucy Wednesday, October 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
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 Friday, October 12, 2018
10:00 AM PDT | 01:00 PM EDT
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). 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.

Roger Cowan Friday, October 12, 2018
10:00 AM PDT | 01:00 PM EDT
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
This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.

Carolyn Troiano Friday, October 12, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar FDA's New Draft Guidance on Software and Device Changes and the 510(k)
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission. You will learn about Substantial Equivalence to support a 510(k) submission.

Eleonora Babayants Friday, October 12, 2018
07:00 AM PDT | 10:00 AM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eleonora Babayants
Change Control Procedures in Regulated Industries
GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. According to these regulations, change control procedures have to be used. Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner.

Tom Fragale Monday, October 15, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Tom Fragale
Mastering Macros in Microsoft Excel
Don't be afraid of macros - learn how to create and use them. When you find yourself repeating actions in Excel - whether it's a five-step sequence you use when formatting a certain cell type or the 30 steps you use when you sort, filter, and print multiple worksheets once a week, the possibility exists that you can automate these actions in the form of a macro. Thereafter, you can perform these sets of actions with a simple keystroke combination, a button in a worksheet, or by using a button in the Quick Access toolbar.

David Nettleton Monday, October 15, 2018
10:00 AM PDT | 01:00 PM EDT
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). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.

Lynn Fountain Wednesday, October 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Risk Based Internal Auditing - Establishing the Methodology
True RBIA incorporates cascading the process through to each individual audit as well as the audit reporting process. The training program will focus on the establishment of a framework or methodology for RBIA and examine how to utilize risk-based questions within the process steps.

Emil W Ciurczak Friday, October 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak

Amer Alghabban Friday, October 19, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Amer Alghabban
3-Hour Virtual Seminar - Good Pharmacovigilance Practice
Pharmacovigilance or drug safety -is a broad term that describes the Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions.

Laura Brown Monday, October 22, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:2 Hours
Price: ¤190.00
by: Laura Brown
2-Hour Virtual Seminar on Data Integrity for GXP Compliance
Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This webx session will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

Robert J. Russell Monday, October 22, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Carolyn Troiano Monday, October 22, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
The 21st Century Cures Act - Expediting New Products and New Product Indications
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

Edwin Waldbusser Tuesday, October 23, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Edwin Waldbusser
Computer System Validation
FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Validation is more than testing. It is testing plus design control and configuration management.

Ginette Collazo Wednesday, October 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Training in Human Error: Reducing Training Related Errors
We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.

Susanne Manz Thursday, October 25, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
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

Danielle DeLucy Thursday, October 25, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
FDA's Expectations from Supplier Management for GMP: Quality Agreements and More
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

Angela Bazigos Friday, October 26, 2018
08:00 AM PDT | 11:00 AM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device
This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).

Charles H. Paul Monday, October 29, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
Project Management for Non-Project Managers -Managing and Controlling the Project
Successful projects require continued care and management to ensure that the project follows the plans correctly and, as a result, leads to the desired results. When unexpected situations occur, you must react promptly to adjust your efforts and keep your project on track.

Lynn Fountain Thursday, November 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Becoming a Chief Audit Executive - Leading the Internal Audit Function
This training program will enumerate the IIA Standards and the auditor's responsibility to abide by the standards. The program will also look at management's expectations of internal audit and detail skills required for internal audit management. It will provide real-world examples and challenges facing today's internal audit.

Susanne Manz Thursday, November 8, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Tom Fragale Friday, November 9, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Tom Fragale
Advanced Formulas & Functions in Excel
In the business world, or within your organization, you probably experience large amounts of data. Maybe the data is about your sales, customers, donations, orders, employees, vendors, expenses, or whatever it may be.

Dr. Afsaneh Motamed Khorasani Friday, November 9, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Danielle DeLucy Friday, November 9, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
How to Conduct Successful Supplier Audits
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.

Carolyn Troiano Friday, November 9, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries.

Susanne Manz Thursday, November 15, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
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.

Amer Alghabban Friday, November 16, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Amer Alghabban
3-Hour Virtual Seminar Data Integrity in Clinical Trials
Clinical trials' data gives an accurate representation of what we measure to evaluate effects of the treatments under comparison. The clinical data recording process, however, as inspected/audited by inspectors/auditors is initiated with the recorded data, either in the Case Report Form, or in some other system, or in an electronic database.

Emil W Ciurczak Friday, November 16, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Lynn Fountain Tuesday, November 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Auditing and Examining Travel and Entertainment Expenses: Expense Reimbursement Fraud
This training program will address why internal controls over travel and entertainment (T&E) expenditures are a critical component of the control environment. Although the topic of travel and entertainment abuse is not one that management likes to address, it is a very important indicator of the adequacy of a company's control environment.

Susanne Manz Thursday, November 29, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Addressing CAPA within a Device Quality System
This webinar will help you ensure an efficient and effective CAPA 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.

Ginette Collazo Thursday, November 29, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Danielle DeLucy Friday, November 30, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Danielle DeLucy
Handling OOS Test Results and Completing Robust Investigations
This training program will provide participants with a 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).

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