Webinar Search Results : 115 Upcoming webinars found.
Edwin Waldbusser Thursday, March 21, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Edwin Waldbusser
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.

Tom Fragale Thursday, March 21, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Tom Fragale
Excel Macros - How to Create and Use them
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.

John Ryan Thursday, March 21, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Ryan
Food Safety, Security and Fraud. Are you ready?
Since 2011 the entire U.S. food supply chain has had to face new challenges due to the signing of the Food and Drug Administration's (FDA) Food Safety Modernization Act (FSMA) into law.

Susanne Manz Thursday, March 21, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Knock, Knock, Who's There? Preparing for an FDA Inspection
Are you ready for that knock on your door? 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.

Jeff Kasoff Friday, March 22, 2019
10:00 AM PDT | 01:00 PM EDT
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?

Joe Lynch Monday, March 25, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Susanne Manz Monday, March 25, 2019
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.

John Chapman Tuesday, March 26, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Danielle DeLucy Tuesday, March 26, 2019
11:30 AM PDT | 02:30 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
Guideline to Aseptic Technique and Clean Room Behavior
This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination.

Prof. Dr. h.c. Frank Stein Tuesday, March 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Prof. Dr. h.c. Frank Stein
ISO 13485 Quality Management System for Medical Device Industry; How to build a Quality Management System for the European Market?
Introduction, who should apply the ISO 13485:2016. Overview about the changes of the ISO 13485:2016. Explaining of each change. Smart and fast ways to implement the changes in your quality management system. Fast track internal audit to approve the changes.

David Nettleton Tuesday, March 26, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Teri C. Soli Wednesday, March 27, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Teri C. Soli
Water System Biofilm Control and Microbial Monitoring Myths
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?

Rotimi Toki Wednesday, March 27, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Rotimi Toki
FDA's Gluten-Free Labelling Rule: How to Comply
The gluten-free market is one of the fastest growing markets worldwide. For the 18 million Americans who suffer from gluten intolerance, gluten sensitivity or celiac disease, gluten-free products are a necessity.

Robert E. Davis Wednesday, March 27, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Robert E. Davis
Managerial Primer for Ensuring Information Security
Usually, a formal ISG program is required to promote information assets safeguarding.ISG programs should ensure the Control Objectives for Information and related Technology (COBIT) framework confidentiality, integrity, availability, compliance, and reliability information criteria compromise does not occur through gaps in controls.

Laura Brown Wednesday, March 27, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Laura Brown
Risk Based Monitoring for GCP Compliance
The rationale for risk based monitoring. The requirements for risk-based monitoring and targeted source data verification (SDV) risks identification.

Dr. Ludwig Huber Wednesday, March 27, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:2 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.

Thomas Nollner Thursday, March 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Thomas Nollner
AML Risk and Responsibilities Related to Foreign Correspondent Banking
There are many risks related to acquiring, maintaining, and supervising correspondent banking relationships which employees and management of financial institution's need to be aware of and actively manage.

Dr. Afsaneh Motamed Khorasani Thursday, March 28, 2019
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.

Carolyn Troiano Thursday, March 28, 2019
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.

Angela Bazigos Friday, March 29, 2019
09:00 AM PDT | 12:00 PM EDT
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.

Joy McElroy Friday, March 29, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Joy McElroy
FDA Adverse Event Reporting
This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries.

Emil W Ciurczak Friday, March 29, 2019
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.

Laura Brown Monday, April 1, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
Compliance with the New ICH GCP Revision 2 Addendum - Know the How?
This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites.

Steven Laurenz Monday, April 1, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Steven Laurenz
Understanding and Implementing a Technology Transfer Process
The purpose of this training is to provide you with an overview of the Technology Transfer. Define technology transfer. Identify New Product transfer process. Identify elements of the business process framework for managing technology transfers. Explain benefits of technology transfer. Determine elements of a successful technology transfer.

Jose Mora Tuesday, April 2, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records

Tom Fragale Tuesday, April 2, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Tom Fragale
Advanced PDF Techniques: Taking PDFs to the Next Level
This topic helps business professionals understand the various PDF applications on the market and what factors to consider when choosing a PDF application.

Ginette Collazo Tuesday, April 2, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Douglas Cohen Wednesday, April 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Douglas Cohen
How to Go Global: 5 Proven Foreign Market Entry Techniques
Due to cost advantages from producing overseas, revenue opportunities from foreign sales and the potential to exploit new technology, tapping international markets holds the greatest potential for growth.

Angela Bazigos Wednesday, April 3, 2019
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.

John E Lincoln Wednesday, April 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
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.

John Ryan Wednesday, April 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: John Ryan
Supply Chain Traceability is Going Digital: What You Can Do to Prepare
RFID, barcode, satellite, Zigbee, cell phones, tablets, packaging, data loggers, the cloud and other traceability alternatives are now available to provide traceability at the item, case, pallet and container levels.

Charles H. Paul Wednesday, April 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
Successful Device Submissions and Approvals - Key Elements
The medical device market is the largest market of all of the life sciences and it is generally valued at upwards of $90 billion with the expectation of continuous growth. This growth demands that the market is continually fed with new and innovative products.

Jonnie T. Keith Wednesday, April 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Jonnie T. Keith
Writing Effective Audit Observations
The key to writing an effective audit observation is having a comprehensive structured process.

Jose Mora Thursday, April 4, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Jose Mora
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples

John Chapman Thursday, April 4, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Chapman
Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements
This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

Robert J. Russell Thursday, April 4, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
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.

Ms. Michael Redmond Thursday, April 4, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Ms. Michael Redmond
Self-Auditing Your Cyber Security Program to Ensure Risk Mitigation
To manage information security in a company, you need self auditing of your cyber security program.

Kelly Thomas Thursday, April 4, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Ginette Collazo Friday, April 5, 2019
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.

Michael Brodsky Friday, April 5, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Michael Brodsky
Quality Control for Microbiological Media and Reagents and Test Kits?
During this webinar, we will discuss a practical QC approach for in-house prepared and/or commercially purchased media, test kits and reagents specifically applicable to microbiology laboratories to assess the acceptability of the performance of analytical materials, to meet not only their requirements, but also to meet the requirements of ISO/IEC 17025.

Joy McElroy Friday, April 5, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Joy McElroy
Writing Validation Master Plans; Best Practices for Writing a Compliant Document
This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs.

Kelly Thomas Monday, April 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Kelly Thomas
How to Write Effective 483 and Warning Letter Responses
This 90-minute course will discuss the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response.

Steven Wachs Monday, April 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Steven Wachs
Estimating Reliability Performance with Accelerated Life Tests
This webinar on Estimating Reliability Performance of products will show how you can use Accelerated Life Testing methods (ALT) to reduce costs, minimize risks and ensure adequate product performance prior to launch.

Angela Bazigos Monday, April 8, 2019
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!
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.

Mike Thomas Monday, April 8, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Mike Thomas
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.

Casper Uldriks Tuesday, April 9, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Donna K Olheiser Wednesday, April 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Donna K Olheiser
NEW - NACHA Operating Rules 2019 and Beyond
The NACHA Operating Rules need to be followed by all financial institutions who process ACH transactions.

Angela Bazigos Wednesday, April 10, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
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.

Edwin Waldbusser Wednesday, April 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Edwin Waldbusser
Medical Device Software Validation Meeting FDA Regulations
This course will teach how to conduct a software validation program for medical devices containing software 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.

Michael Esposito Wednesday, April 10, 2019
10:00 AM PDT | 01:00 PM EDT
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.

David Nettleton Thursday, April 11, 2019
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).

Dr. Ludwig Huber Thursday, April 11, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
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.

Danielle DeLucy Thursday, April 11, 2019
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 webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.

Roger Cowan Thursday, April 11, 2019
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
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.

Angela Bazigos Friday, April 12, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Carolyn Troiano Monday, April 15, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar on Data Integrity and Governance for Computer Systems Regulated by FDA
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry.

Joe Lynch Monday, April 15, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Joe Lynch
Winning Sales Strategies for 3PL, Transportation and Logistics Professionals
The 3PL (transportation, logistics, warehousing and technology) space is very crowded.The average salesperson is not meeting sales goals and their message can't cut through the clutter.

Ms. Michael Redmond Monday, April 15, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Prof. Dr. h.c. Frank Stein Monday, April 15, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Prof. Dr. h.c. Frank Stein
MDSAP - How to Implement MDSAP-Requirements into your ISO 13485 Quality Management System?
This course will give an introduction into the Medical Device Single Audit Program (MDSAP).

John N. Zorich Tuesday, April 16, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
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.

Teri C. Soli Tuesday, April 16, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Angela Bazigos Tuesday, April 16, 2019
12:00 PM PDT | 03:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Project Management for Computer Systems Validation
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.

Susanne Picard Tuesday, April 16, 2019
08:00 AM PDT | 11:00 AM EDT
Duration:60 Minutes
Price: ¤150.00
by: Susanne Picard
Current Regulatory Landscape with the new Canadian Cannabis Act
An overview of what the new Cannabis Act and related regulations and guidelines are, pertaining to the numerous Cannabis related activities in Canada and how it changed the broader regulatory environment.

Angela Bazigos Wednesday, April 17, 2019
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.

Todd B. Graham Wednesday, April 17, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Todd B. Graham
SOP's for Bioanalytical Methods Validation
The webinar will include the following critical information you will need:

Jonnie T. Keith Wednesday, April 17, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Jonnie T. Keith
Putting the Quality in Audit Reports
How well you communicate that information is critical to getting management's acceptance of your findings and their agreement with your recommendations.

John Ryan Wednesday, April 17, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John Ryan
How Blockchain Will Become the Basis for An Integrated Food Safety System (IFFS) ?
This webinar will discuss how blockchain will impact the food industry and how the likely food safety and quality inputs to this invoicing system are likely to determine your company's financial future.

Jose Mora Thursday, April 18, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.

Mike Thomas Thursday, April 18, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Mike Thomas
Excel Data Visualization - Charts and Infographics
In this session, participants will learn how to visually represent your data using both traditional charts (bar charts, line charts etc.) as well as how to do the same using some of Excel's non-charting tools.

Tom Fragale Friday, April 19, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Tom Fragale
Power BI: Driving Results with Your Data
In today's fast-paced, high-tech, competitive business environment, analytics, data visualization and Business Intelligence (BI) are the hot topics many firms and professional recruiters seek.

Ginette Collazo Friday, April 19, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
This training program will offer attendees an understanding of human error, its factors and causes.

Tom Fragale Monday, April 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Tom Fragale
Harness the Power of SharePoint: A Primer on Setup and Management
SharePoint has become the standard way for companies and organizations to share relevant info and files with other people in the company and with people outside of the company as well.

Dr. Ludwig Huber Tuesday, April 23, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Robert J. Russell Tuesday, April 23, 2019
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.

John E Lincoln Tuesday, April 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John E Lincoln
The Most Serious FDA 483s - How to Avoid them
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.

Susanne Manz Tuesday, April 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Susanne Manz
Turn a Culture of Quality Into a Competitive Advantage
A culture of quality is a powerful tool for creating an effective and efficient Quality Management System. A culture of quality is not accidental but can be purposefully nurtured and developed.

John Chapman Wednesday, April 24, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Chapman
Failure Modes and Effects Analysis - An effective Risk Management Tool
This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

Douglas Cohen Wednesday, April 24, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Douglas Cohen
How to Create an Export Compliance Program Under the Export Administration Regulations(EARs)
The US Government regulates the export of information, commodities, technology, and software considered important to US national security, economic competition, and foreign policy.

Edwin Waldbusser Thursday, April 25, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Steven Wachs Thursday, April 25, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Steven Wachs
Fractional Factorial Experiments for Screening Studies
In this webinar attendees will learn the key concepts behind Design of Experiments (DOE) and the use of DOE for Process and Product Optimization.

Donna K Olheiser Friday, April 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Donna K Olheiser
Exploring the "Newly Approved" Enhancements to Same Day ACH
Same Day ACH (SDA) was implemented in three phases, beginning Sept of 2016 and ending in March 2018.

Ms. Michael Redmond Friday, April 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Ms. Michael Redmond
Taking Risk Management to the next level. Are you Prepared?
We will cover creating, implementing, and managing Enterprise Risk Management according to standards, best practice and proven methods.

John Ryan Monday, April 29, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John Ryan
Artificial Intelligence (AI) in the Food Supply Chain - Current and Future Potential
From robotic planting and harvesting systems through self-driving trucks, inspection systems, traceability, robotic pick and place loading systems, robotic grading systems, food processing systems, pick and place, inventory control and other areas, Artificial Intelligence (AI) is planning major changes that will impact the food supply chain in ways we can only imagine.

Carolyn Troiano Tuesday, April 30, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
In-Depth Testing of Computer Systems Regulated by FDA
This webinar will cover all aspects of testing to ensure that a computer system regulated by FDA "does what it purports to do," as per the guidance on computer system validation (CSV) from FDA, first issued in 1983.

Susanne Manz Tuesday, April 30, 2019
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.

Ginette Collazo Tuesday, April 30, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Ginette Collazo
3-Hour Virtual Seminar on Human Error Reduction in GMP Related Environments
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.

Michael Abitz Wednesday, May 1, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Ginette Collazo Wednesday, May 1, 2019
12:00 PM PDT | 03:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Ginette Collazo
3-Hour Virtual Seminar on the Human Error Tool Box: A Practical Approach to Human Error
This course provides a practical approach that will allow you to understand human behavior in the workplace, to assess your current human reliability situation, and support human error reduction efforts at your site.

Steven Laurenz Thursday, May 2, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Steven Laurenz
Quality Risk Management Overview
Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM.

Todd B. Graham Friday, May 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Todd B. Graham
Quality Control for Microbiological Media and Reagents
This webinar will help you develop a quality control program that fits your microbiological laboratory's needs. We will explicitly not cover any serological, immunological or molecular tests.

Steven Wachs Tuesday, May 7, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Steven Wachs
Statistical Hypothesis Tests: Concepts and Applications
This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes.

Ms. Michael Redmond Tuesday, May 7, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Ms. Michael Redmond
Business Continuity Management: Architect and Implement Solution
Learn to properly prepare for an impact to the business for any organization. We will cover how to identify, analyze and document the events and environmental surroundings that can adversely affect the organization.

Dr. Ludwig Huber Wednesday, May 8, 2019
10:00 AM PDT | 01:00 PM EDT
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.

John E Lincoln Wednesday, May 8, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Edwin Waldbusser Thursday, May 9, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Prof. Dr. h.c. Frank Stein Monday, May 13, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Prof. Dr. h.c. Frank Stein
ISO 62304 How to Create a Medical Software Development File?
This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible.

Susanne Manz Monday, May 13, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Michael Esposito Tuesday, May 14, 2019
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.

Donna K Olheiser Wednesday, May 15, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Donna K Olheiser
NEW NACHA Rule: Third-Party Sender Registration - Are you in Compliance?
Learn what a Third-Party Sender (TPS) is and how this impacts you as a participant in the ACH Network (as an ODFI or TPS). Attend this training session to help identify and determine if you have a Third-Party Sender relationship.

John N. Zorich Wednesday, May 15, 2019
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.

Thomas Bento Thursday, May 16, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Susanne Manz Thursday, May 16, 2019
12:00 PM PDT | 03:00 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.

Michael Abitz Tuesday, May 21, 2019
10:00 AM PDT | 01:00 PM EDT
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.

David Nettleton Tuesday, May 21, 2019
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.

John N. Zorich Wednesday, May 22, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Dr. Ludwig Huber Thursday, May 23, 2019
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.

Angela Bazigos Friday, May 24, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Ms. Michael Redmond Friday, May 24, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Ms. Michael Redmond
Are you responsible for Enterprise Risk Management Compliance: How to conduct a Compliance Gap Analysis for ERM, how to get started and what to expect?
This webinar will explain how to conduct a compliance gap analysis for Enterprise Risk Management (ERM). Attendees will learn best practices to ensure ERM compliance.

Susanne Picard Tuesday, May 28, 2019
08:00 AM PDT | 11:00 AM EDT
Duration:60 Minutes
Price: ¤150.00
by: Susanne Picard
Overcoming Obstacles of the Canadian Drug Regulatory Landscape
Learn what common obstacles are in the Canadian Drug Development and Approval Process and how to avoid them or manage them efficiently should they occur.

Donna K Olheiser Wednesday, May 29, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Donna K Olheiser
Conducting YOUR "NEW 2019" Annual ACH Rules Compliance Audit- a Step-by-Step Guide
The NACHA Operating Rules and Guidelines require that all participating depository financial institutions, third-party senders and third-party service providers that provide ACH services conduct an annual ACH audit to be performed by December 31 of each year (ACH Rules, Article 1).

Susanne Manz Wednesday, May 29, 2019
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.

Casper Uldriks Tuesday, June 25, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Susanne Picard Tuesday, June 25, 2019
08:00 AM PDT | 11:00 AM EDT
Duration:60 Minutes
Price: ¤150.00
by: Susanne Picard
Demystifying the Canadian Drug and Health Products Regulatory Landscape
In this webinar, we will demystify broadly what the current Canadian regulatory landscape is for efficient Canadian development initiatives.

Casper Uldriks Tuesday, July 16, 2019
09:00 AM PDT | 12:00 PM EDT
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 PDT | 01:00 PM EDT
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.