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: April 25, 2016

Description: Quality assurance expert Susan Schniepp discusses how to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites. She covers:

  • Planning and project management;
  • Transfer of analytical assays;
  • Small-scale verification at receiving site; and
  • Pre-GMP engineering runs.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Susan J. Schniepp, Fellow, Regulatory Compliance Associates, Inc.

Recorded on: April 21, 2016

Description: Biosimilars expert Nathan Doty examines the outlook for the industry and discusses:

  • Immunogenicity;
  • Loss of efficacy; and
  • Switching without interchangeability.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Nathan Doty, Associate Director, Biotherapeutics Regulatory Affairs, Abbvie

Recorded on: April 20, 2016

Description: Clinical trial policy advisor Beverly Lorell discusses how to keep your focus on data collection and integrity. Topics include:

  • Inadequate recordkeeping;
  • Inadequate accountability for the investigational product;
  • Inadequate communication with the IRB;
  • Inadequate subject protection — failure to report AEs and informed consent issues; and
  • Inadequate monitoring.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Beverly Lorell, Senior Medical and Policy Advisor, FDA & Life Sciences Practice Group, King & Spalding

Recorded on: April 13, 2016

Description: Regulatory specialist Michele Buenafe discusses the current regulatory climate for mobile medical apps, issues that are yet to be resolved and expectations for future developments and the direction of regulatory policy in this space. She covers:

  • Mobile medical apps guidance;
  • FDASIA Health IT Report;
  • FDA enforcement discretion; and
  • FTC enforcement.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Michele Buenafe, Partner, FDA Practice, Morgan, Lewis & Bockius, LLP

Recorded on: April 12, 2016

Description: Chinese regulatory expert John Balzano breaks down the explosion of new and revamped regulations for medical devices in China. He discusses:

  • Significant changes in the basic requirements for registering a medical device in China;
  • Major changes in basic GxPs, including in the areas of manufacturing, distribution and use of devices in medical institutions;
  • How China is implementing its blueprint for drug and device reform; and
  • Impact of the proposal for medical device adverse event reporting and how the changes to the Advertisement Law in 2015 can affect the way devices are advertised and labeled.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: April 5, 2016

Description: Global regulatory affairs specialists Fernando Ferrer and Silvia Bendiner present the economic and regulatory outlook in various Latin American states. They discuss:

  • Argentina;
  • Brazil;
  • Colombia;
  • Mexico; and
  • Puerto Rico.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Fernando Ferrer, Head of Global Consulting in Business and Operations, Multinational Partnerships, LLC and Silvia Bendiner, Director of Regulatory Affairs for Latin America, Mapi Group

Recorded on: March 31, 2016

Description: Consultants Glen Potvin and Lesley Stewart describe a proven approach to uncover and address data integrity issues within companies and their partner networks. They discuss:

  • How to establish a “right to win mentality” through proactive steps and surveillance activities;
  • How to characterize the scale and scope of issues;
  • How to design and deploy the remediation strategy; and
  • Best practices for tailoring solutions to the problems identified.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Glen Potvin, Senior Director, and Lesley Stewart, Principal Consultant, Quintiles Consulting

Native Advertising
54 minutes

Recorded on: March 31, 2016

Description: Attorneys Anuj Desai and Alan Minsk explain how to minimize risks of FTC and FDA enforcement for the use of native advertising techniques. They cover:

  • The FTC definition of deceptive advertising;
  • How to ensure disclosure language is clear and visible; and
  • How to apply FDA rules on labeling and promotion in the absence of guidance specific to native advertising.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Anuj Desai and Alan Minsk, Partners, Arnall Golden Gregory

Recorded on: March 30, 2016

Description: Industry analysts Daniel Matlis and Ethan Smith show you how innovative life science companies have addressed the challenges of increasingly externalized operations. They discuss:

  • Why recent regulatory trends are putting current manufacturing and supply chain processes at risk;
  • How to improve visibility and management of quality across your supply chain; and
  • Which strategies adopted by leading life science companies have led to increased quality in a global and outsourced environment.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Daniel R. Matlis, President, Axendia, and Ethan Smith, Director of Product Strategy, Vault QualityDocs, Veeva Systems

Recorded on: March 24, 2016

Description: Regulatory counsel Kurt Karst explains how to use the 505(b)(2) drug approval path to fast-track new products. He discusses:

  • The nuances and shifts in the development of the 505(b)(2) route to approval;
  • Current FDA interpretations affecting 505(b)(2) applications;
  • Pitfalls to avoid; and
  • Secrets to interpreting new legal challenges to the 505 process, including citizen petitions, looming lawsuits and the assignment of therapeutic equivalent codes.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Kurt Karst, Director, Hyman, Phelps & McNamara