The Webinar Training Pass

Now get all the training you need – all in one place, and all for one low price!

The FDAnews Webinar 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.

PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!

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litigator Mark Carlisle Levy and mechanical engineer Richard Underwood analyze the implications of the FDA’s May 2016 draft guidance for stakeholders in the digital manufacturing industry.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

Recorded on: Aug. 9, 2016

Description: Regulatory attorney discusses implementation of Section 503B, including outsourcing facility registration and the enforcement policies affecting traditional compounding pharmacies that rely on Section 503A. She covers:

  • How the FDA has interpreted the restrictions in Section 503A, including the restrictions on so-called anticipatory compounding;
  • How the FDA has interpreted Section 503B, such as its restrictive reading of a “facility at one geographic location or address,” as used to define an outsourcing facility; and
  • Some of the more extensive enforcement actions in the past year against compounding entities or pharmacists.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Joanne Hawana, Of Counsel, Mintz Levin

Recorded on: Aug. 4, 2016

Description: Compliance expert and former FDA official David Chesney explains how to prepare for and manage preapproval inspections. He discusses:

  • Guidance on inspection activities — from drug development to QA controls to document reviews;
  • How to respond to a 483 if you get one; and
  • How to best handle document requests to avoid problems.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC

Recorded on: Aug. 2, 2016

Description: Former director of the FDA Office of Orphan Products Development (OOPD) Timothy Coté explains the ins and outs of obtaining orphan drug status. He discusses:

  • The differences in obtaining approval for orphan vs. non-orphan drugs;
  • Detail-prevalent criteria for orphan drugs; and
  • Clinical superiority in orphan drug designation.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Timothy R. Coté, Principal & Chief Executive Officer, Coté Orphan

Recorded on: July 27, 2016

Description: Quality systems expert Susan Reilly explains how using the Medical Device Single Audit Program model in your internal audits to make sure you meet international regulators’ requirements. She discusses:

  • How to identify and understand the MDSAP requirements as interpreted by the various regulatory authorities;
  • How to determine gaps in your current documentation; and
  • How to “score" your current quality system.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Susan Reilly, President & Principal Consultant, Reilly Associates LLC

Recorded on: July 26, 2016

Description: Regulatory expert Gordon Richman discusses how to craft effective, timely responses needed to keep 483s from escalating into warning letters and warning letters into serious trouble. He covers:

  • Techniques to successfully respond to Form 483s in 15 days or less;
  • How to evaluate the intent of the observation; and
  • What the FDA expects when reviewing Form 483 and warning letter responses.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Gordon B. Richman, Vice President and Regulatory Compliance Counsel, Danaher Diagnostics Platform at Beckman Coulter