The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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Webinar Training Pass
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.
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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.
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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.
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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.
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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.
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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