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: Feb. 22, 2017

Description: Attorneys Steve Terman and Gordon Schatz explain how to strategically blend reimbursement with FDA regulatory. They discuss:

  • How to evaluate the 510(k)/PMA options in terms of maximizing reimbursement;
  • What key reimbursement questions must be asked in advance of selecting the FDA approval pathway;
  • How to decide what data is needed to support both a favorable FDA outcome and obtain the desired reimbursement; and
  • The 7 steps to reimbursement success.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Steve Terman, Principal Attorney, Olson Frank Weeda Terman Matz, and Gordon Schatz, President, Schatz Reimbursement Strategies

Recorded on: Feb. 15, 2017

Description: Food and drug law expert Jim O’Reilly outlines the major changes the act will make in the way drugmakers operate. He discusses:

  • How Congress has thrown a curve at the FDA’s often stringent review process, enabling far broader acceptance of submitted experience data;
  • How to avoid supplemental NDAs on new indications by pitching to insurers for their provider formularies without FDA control;
  • How to utilize patient input and patient experiences in pre-approval submissions; and
  • How to accelerate approval of your new uses for drugs and still stay in compliance with current FDA regulation and guidance.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Jim O’Reilly, Professor of Law (Retired), University of Cincinnati College of Law

Recorded on: Feb. 9, 2017

Description: International trade attorney Jennifer Diaz discusses opportunities and challenges for doing business in Cuba. She covers:

  • FDA and other government obstacles that continue to impede U.S.-Cuban commerce;
  • What kinds of medical products and foods can be exported to Cuba under the latest FDA and Customs guidance; and
  • Details and nuances of the latest trade regulations as they relate to the Cuban trade embargo.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Jennifer Diaz, Founding Partner, Diaz Trade Law, P.A.

Recorded on: Feb. 8, 2017

Description: PDA task force members Denyse Baker, Emma Ramnarine, Melissa Seymour and Dr. Anders Vinther discuss PDA’s program to reduce hurdles to pharmaceutical manufacturing innovation caused by disparate national regulations that discourage changes. The program’s objectives include:

  • Fostering a science and risk-based approach to post-approval change management and regulatory decisionmaking;
  • Encouraging international convergence/standardization; and
  • Managing post-approval changes through the use of an effective Product Quality Systems (PQS).

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Dr. Anders Vinther, Chief Quality Officer, Sanofi Pasteur; Emma Ramnarine, Senior Director, Head of Global Biologics QC Network, Genentech/Roche; Melissa Seymour, Vice President of Global Quality Control, Biogen, Inc.; Denyse Baker, Senior Advisor, Scientific and Regulatory Affairs, PDA; former Quality Assurance Specialist, Office of New Drug Quality Assessment, CDER, FDA

Recorded on: Feb. 1, 2017

Description: Food and drug law expert Jim O’Reilly explains new mandates set by the 21st Century Cures Act and how they will change medical device regulations in several key areas, including data development, clinical approvals, breakthrough devices, inspections and humanitarian device exemptions. He discusses:

  • How Congress has thrown a curve at the FDA’s stringent review process, enabling far easier approval for lower-risk devices;
  • How the FDA intends to implement the new acceptance program for foreign medical device research; and
  • What effect the act’s emphasis on “less burdensome” regulations will have on the industry.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Jim O’Reilly, Professor of Law (Retired), University of Cincinnati College of Law

Recorded on: Jan. 31, 2017

Description: Medical device expert Grace Fu Palma discusses recent developments in Chinese manufacturing regulations, including new GMPs, self-inspections, foreign inspections and trends in enforcement. She covers:

  • Implementation of the new GMPs, including the procedural rules for inspections;
  • 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, including recent examples.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Grace Fu Palma, CEO, China Med Device, LLC

Recorded on: Jan. 30, 2017

Description: Regulatory attorney Alan Minsk discusses the FDA’s latest rules on what speech is and is not protected. He covers:

  • FDA’s enforcement against pre-approval promotion;
  • The PhRMA/BIO principles on sharing truthful and non-misleading information;
  • FDA's recent public hearing on off-label communications; and
  • Non-FDA-related issues to consider with off-label promotion.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Alan G. Minsk, Partner and Leader of the Food and Drug Practice Team, Arnall Golden Gregory

Recorded on: Jan. 27, 2017

Description: Quality assurance expert James Shore provides up-to-date information on purchasing controls for quality assurance and control of purchased components, services or finished medical devices. He covers:

  • Performing a gap assessment to the new ISO requirements and QSR expectations;
  • Reviewing supplier quality agreements for key elements; and
  • Performing and documenting risk assessment of suppliers.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: James Shore, Director of Quality Assurance/Regulatory Affairs, Titan Medical, Inc.

Recorded on: Jan. 25, 2017

Description: Regulatory law expert Darshan Kulkarni explains the FDA’s three draft guidances on compounding. He discusses:

  • The latest areas of FDA enforcement in compounding;
  • Requirements for 503A (traditional compounders) and 503B (outsourcing facilities);
  • How to establish a core FDA inspection team; and
  • How to create an appropriate FDA response to a Form 483.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm

Recorded on: Jan. 19, 2017

Description: Medical device regulatory expert Dan O’Leary explains the nuances of the FDA’s requirements for corrections and removals. He covers:

  • The difference between corrections and removals;
  • The difference between Part 7 and Part 806 recall rules;
  • How to determine if you need to report to the FDA; and
  • How the new cybersecurity guidance applies to corrections and removals.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, Ombu Enterprises LLC