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.

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Webinar Training Pass

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

Transcript: Download the transcript

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.

Presentation: Download the presentation

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

Recorded on: Aug. 31, 2016

Description: Computer system validation expert David Harrison discusses best practices and available options for validating spreadsheets, including:

  • Exactly what the FDA looks for and why;
  • Spreadsheet validation "gaps" the FDA is targeting;
  • How to generate spreadsheet specifications and qualification protocols; and
  • How to test spreadsheets and macros.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: David Harrison, Principal Consultant, CSV Compliance Limited

Recorded on: Aug. 30, 2016

Description: China regulatory expert John Balzano provides an analytical introduction to China’s medical device regulations including GMPS, self-inspections, foreign inspections and enforcement trends and requirements for importing devices. He discusses:

  • Implementation of the new GMPs, including the procedural rules for inspections, preparation, communicating with inspectors, resolving issues and potential penalties;
  • Transfer of manufacturing sites and amendment of manufacturing and device licenses;
  • Policies and rules on contract manufacturing for medical devices; and
  • Handling self-inspections and evaluations of past compliance.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: John Balzano, Special Counsel, Covington and Burling, LLP

Recorded on: Aug. 18, 2016

Description: Quality systems and operations expert Dan O’Leary outlines the revisions made to ISO 13485 and discusses transitioning to the new certification requirements. He covers:

  • Potential conflicts with the Quality System Regulation;
  • The role of ISO 13485:2016 in the Medical Device Single Audit Program and Canada’s plan to adopt it; and
  • The transition plan for the EU Harmonized Standard.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: Aug. 17, 2016

Description: Regulatory experts John O’Brien and Christopher Ripple discuss some of the practical considerations to take into account when drafting and documenting an FSMA-compliant food defense plan. Topics include:

  • Key distinctions between the Food Defense Rule and the Hazard Analysis and Critical Control Points (HAACP) and Hazard Analysis and Risk-Based Preventive Controls (HARPC) analyses;
  • Unresolved issues and challenges; and
  • Why the Food Defense Rule requires significant education and outreach.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: John F. O’Brien III, Counsel, and Christopher A. Ripple, Associate, McGuireWoods LLP

Recorded on: Aug. 16, 2016

Description: Commercial litigator Mark Carlisle Levy and mechanical engineer Richard Underwood analyze the implications of the FDA’s May 2016 draft guidance for stakeholders in the digital manufacturing industry. They discuss:

  • The FDA’s view of 3D printing;
  • The FDA’s view of what needs to be regulated;
  • How to submit a device for approval;
  • Liability issues digital manufacturers face; and
  • How to address risk management and product liability issues.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Mark Carlisle Levy, Member, Eckert Seamons, and Richard Underwood, Manager, Exponent

Recorded on: Aug. 11, 2016

Description: Combination products specialist Jennifer Newberger discusses the expected outcomes of recent FDA actions, and the impact of the FDA’s historical approach to classifying combination products. Topics include:

  • Keys to drafting a request for designation (RFD);
  • Critical information to include in an RFD;
  • The role of the newly established Combination Products Policy Council; and
  • Mechanisms for appeals.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Jennifer Newberger, Director, Hyman, Phelps & McNamara, P.C.

Recorded on: Aug. 10, 2016

Description: Three noted regulatory experts discuss what legal and regulatory risks devicemakers face with connected medical devices and how to mitigate them. They cover:

  • Legal risks presented by hackers;
  • What FDA is really looking for by recommending that you identify and address cybersecurity risks as part of its required design and control validation activities for medical devices;
  • How to comply with the provisions of the Cybersecurity Information Security Act of 2015 that affect all medical device manufacturers; and
  • How to share cyber threat information without incurring additional risk.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Scott Danzis, Partner, Jennifer Martin, Counsel and Mark Young, Special Counsel, Covington & Burling