The Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs, feature top consultants, expert speakers and FDA officials.

If you are already a Training Pass member login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video click the "Download Presentation" link.

Many of our webinars have been pre-approved by RAPS as eligible for up to 1.5 credits toward a participant’s RAC recertification. Please enter keyword RAPS below for a list of eligible on-demand webinars.

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Webinar Training Pass

Recorded on: Oct. 19, 2016

Description: Attorney Anna Laakmann explains how regulatory noncompliance can form the basis of a False Claims Act (FCA) enforcement action. She discusses:

  • How to avoid FCA claims based on promotion and marketing;
  • Common scenarios in which regulatory violations can give rise to FCA liability; and
  • What a qui tam action is and the role that employees and other whistleblowers play in enforcing the FCA against drug and device manufacturers.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Anna Laakmann, Of Counsel, Greenberg Traurig

Recorded on: Oct. 13, 2016

Description: FDA and industry experts discuss the effect UDI implementation will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient. Topics include:

  • The FDA’s intent to significantly improve device evaluation and decisionmaking through the adoption of UDI across the device ecosystem;
  • Opportunities to go beyond compliance and leverage UDI for the future;
  • The value of managing the device identifier (DI) and production identifier (PI) throughout the product lifecycle; and
  • Effects of UDI implementation in terms of post-market quality management and future innovation efforts, including precision medicine initiatives.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Terrie Reed, FDA Senior Advisor for UDI Adoption; Daniel R. Matlis, Founder and President, Axendia; and Jean Colombel, Vice President, Life Sciences Industry, Dassault Systemes

Recorded on: Oct. 12, 2016

Description: Clinical trial management experts Jason James and Vince Postill discuss the current and emerging demands on clinical trial supply, and how to design a supply chain that is fit for future challenges. They cover:

  • Developing an on-demand packaging model that meets country-specific regulatory and language labeling requirements;
  • Latest packaging and labeling technologies;
  • Data-driven label design and printing; and
  • Language and phrase management tools.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Jason James, Senior Manager, Labeling and Innovation, Bristol-Myers Squibb and Vince Postill, Senior Vice President, Global Product & Business Development, Prisym ID

Recorded on: Oct. 5, 2016

Description: Connectivity specialist Tim Gee provides insight into the current regulatory landscape for digital devices. He covers:

  • Market trends and government regulations, including the Joint Commission, FDA, and FTC guidance on mobile apps and other digital products;
  • How regulatory changes impact risk management, verification testing and the use of OTS components; and
  • Tactics and methods to ease the digital transformation and provide your company with a competitive advantage.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Tim Gee, Principal and Founder, Medical Connectivity Consulting

Recorded on: Sept. 29, 2016

Description: Operations management expert Dan O’Leary explains the fundamental requirements of medical device process validation and uses warning letters to illustrate best practices. He discusses:

  • The role of IQ, OQ and PQ in process validation;
  • Issues of parameter control, data collection and data analysis and how to apply them to production runs;
  • The QSIT inspection approach and how FDA Investigators apply it; and
  • New requirements introduced in the recently revised ISO 13485:2016.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, President, Ombu Enterprises, LLC

Recorded on: Sept. 28, 2016

Description: Sparta System’s Joe Humm discusses how companies are leveraging information for benchmarking, incorporating learnings into their business processes and making better real-time decisions. Topics include:

  • Company and market dynamics;
  • Technology solutions; and
  • Data-driven storytelling.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Joe Humm, Vice President, Global Sales Operations, Sparta System

Recorded on: Sept. 27, 2016

Description: Quality management experts Susan Schniepp and Linda Biava dig into the details of data integrity and how to detect problems. They cover:

  • Data integrity code of conduct;
  • Who is responsible for data integrity;
  • Frequency of audits; and
  • Building a culture of quality.

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Transcript: Download the transcript

Speakers: Susan J. Schniepp, Fellow, and Linda Biava, Regulatory Specialist, Regulatory Compliance Associates, Inc.

Recorded on: Sept. 21, 2016

Description: Law professor William Janssen provides a practical explanation of eight recent key decisions that affect what regulatory affairs does every day, in ways you may not have realized before. Cases include:

  • Amarin v. United States
  • United States v. Quality Egg
  • Caplinger v. Medtronic, Inc.
  • Yates v. Ortho-McNeil-Janssen Pharma

Presentation: Download the presentation

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Speaker: William Janssen, Professor of Law, Charleston School of Law

Recorded on: Sept. 14, 2016

Description: Attorneys Stacy Ehrlich and Will Woodlee explain what OTC drug products require premarket approval, labeling and promotion rules, and common but avoidable mistakes in marketing OTC drug products. They discuss:

  • How the FDA determines whether it will regulate a product as a drug and whether the drug must be dispensed only with a healthcare provider’s prescription;
  • The difference between OTC drug labeling and advertising, and who regulates the content of these materials; and
  • What needs to appear on OTC drug labeling and the common mistakes made by industry.

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Transcript: Download the transcript

Speakers: Stacy Ehrlich and Will Woodlee, Partners, Kleinfeld, Kaplan & Becker, LLP

Recorded on: Sept. 7, 2016

Description: International pediatric research expert Martine Dehlinger-Kremer explains the pediatric clinical trials regulations drugmakers need to understand when they begin development of a new product. She covers:

  • The impact of deferrals and waivers to planned pediatric clinical trial requests;
  • Technical requirements for pediatric clinical trials mandated by the International Council on Harmonization and the EWG Working Group; and
  • How to streamline paperwork on pediatric clinical trials in conjunction with the recently implemented guideline on pediatric study plans.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Martine Dehlinger-Kremer, Global Vice President, Medical & Regulatory Affairs, SynteractHCR