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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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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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Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
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Webinar Training Pass
MDUFA 2012
78 minutes
Description: Noted expert and former FDA official Steven Niedelman is joined by legal analyst Pamela Forrest to provide detailed insight on the 2012 MDUFA reauthorization, device user fees, FDA performance goals, and other key provisions affecting medical devices, including:
- Conflict of interest scenarios;
- Patient participation in product discussions; and
- Nanotechnology issues.
Presentation: Download the presentation
Speakers: Steven Niedelman, Lead Quality Systems and Compliance Consultant to the FDA & Life Sciences practice team, King & Spalding and Pamela Furman Forrest, Partner, King & Spalding
Insider Insight on PDUFA V
89 minutes
Description: An expert legal team maps the complex PDUFA V requirements. Topics covered include;
- The path to market provisions;
- Distribution and supply provisions;
- User fees and performance goals.
Presentation: Download the presentation
Speakers: Peter Barton Hutt, Senior Counsel, Covington & Burling; Erika Lietzan, Partner, Covington & Burling; Scott Cunningham, Partner, Covington & Burling and Stefanie Doebler, Special Counsel, Covington & Burling
Description: On July 3, 2012, the FDA released a proposed rule on the unique device identification (UDI) system, ending a year-long delay in finalizing the much-anticipated safety mechanism. The 165-page comprehensive rule touches all aspects of the medical device industry. The FDA maintains that the UDI system helps reduce the rate of death caused by faulty devices, which the agency estimates at 17,700 over the past five years. Jeffery Shuren, director of CDRH, called the UDI rule "a major game-changer." The FDA receives numerous device-related adverse event reports, but often can't tell what device the patient is referencing. UDI makes aggregating reports easier, but at what time and cost to industry? Across the board — from supplier, provider, distributor, to consumer — who is ready? Listeners will learn what's hidden in the rule's 165 pages and where to start the journey to implementation. Siobhan O'Bara and John Roberts of GS1 will provide clarification on creating a mandatory system of unique device identifiers.
Presentation: Download the presentation
Speakers: Siobhan O'Bara, Healthcare Vice President, GS1 US and John Roberts, Director of Healthcare, GS1 US
Medical Device Reimbursement De-Mystified
77 minutes
Description: In this webinar, legal analyst Ed Dougherty shows how to:
- Develop a single, integrated regulatory/market access strategy and point of contact;
- Conduct an early landscape assessment to develop a milestone-driven strategic plan; and
- Create a new gap analysis technique to evaluate assets, determine what to leverage and what to build; and
- Update a reimbursement strategy to anticipate new market dynamics.
Presentation: Download the presentation
Speaker: Ed Dougherty, Senior Healthcare Advisor, Arent Fox
Device Off-Label Promotion
86 minutes
Description: Regulatory experts James Ravitz and Stephanie Trunk dissect regulations governing off-label promotion. Topics covered include:
- Key areas of risk and potential red flags;
- Responding to public and non-public unsolicited requests for information;
- Implications of the responsible corporate officer doctrine; and
- How a violation becomes a false claims case.
Presentation: Download the presentation
Speakers: James Ravitz, Partner, Arent Fox LLP and Stephanie Trunk, Associate in the Health Law Group, Arent Fox LLP
Description: Leading legal analysts Erika Lietzen and Laura Sim deconstruct the FDA’s biosimilars guidance and the comments it received and what FDA enforcement and emphasis might look like in the future. They also highlight important areas the guidance doesn’t address, such as:
- Pediatric testing; and
- When a regulated entity should construct its own defensible compliance programs instead of waiting for overt FDA direction.
Presentation: Download the presentation
Speakers: Erika Lietzen, Partner, Covington & Burling and Laura Sim, Associate in Food & Drug practice group, Covington & Burling
510(k) Process Changes Survival Guide
69 minutes
Description: A trio of legal experts guides devicemakers through the 510(k) process, focusing on:
- How to better understand and produce compliant 510(k) content;
- How to handle a predicate event; and
- How to understand when a regulated entity should issue a 510(k).
Presentation: Download the presentation
Speakers: Neil O'Flaherty, Principal, Olsson Frank Weeda Terman Matz PC (OFW Law); Evan Phelps, Principal, OFW Law and Nancy Mathewson, Associate, OFW Law
Part 806 Device Recalls
73 minutes
Description: Regulatory compliance expert Gordon Richman discusses how to handle recalls under Part 806 of the Quality System Regulations. Richman focuses on:
- Key differences between Parts 7 and 806 when it comes to device recall strategy;
- Unique challenges to accurate reportability; and
- Ways to evaluate the proper recall criteria for a devicemaker.
Presentation: Download the presentation
Handout: 21 CFR Part 806 Process Flow
Speaker: Gordon B. Richman, Vice President, Strategic Compliance Consulting and General Counsel, EduQuest
Description: Consultants Dean Cirotta and William Ment cite the most common GMP deficiencies found in dietary supplement manufacturing and the best way to handle FDA inspections. This presentation provides:
- An overview of FDA inspections and regulatory actions;
- Review of the FDA’s compliance program for dietary supplements;
- What the agency considers the major deviations that often result in warning letters; and
- Strategies for responding to warning letters and 483s.
Presentation: Download the presentation
Speakers: Dean Cirotta, Vice President, EAS Consulting Group and William Ment, Contract Consultant, EAS Consulting Group
Medical Device Complaint Management
86 minutes
Description: Susan Reilly, a long-time consultant on medical device complaint management issues, offers a clearer understanding of how to handle complaints. She discusses:
- The essential components of a complaint management system;
- How to handle failure investigations; and
- Adverse event evaluation and recordkeeping.
Presentation: Download the presentation
Speaker: Susan Reilly, Owner and Principal Consultant, Reilly & Associates LLC