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Webinar Training Pass
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.
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Speaker: Martine Dehlinger-Kremer, Global Vice President, Medical & Regulatory Affairs, SynteractHCR
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.
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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.
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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.
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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.
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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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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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Transcript: Download the transcript
Speaker: David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC