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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.
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.
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
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
Description: Environmental monitoring expert Kenneth Christie provides explanations of regulatory requirements for EM programs, facility design, personnel training and aseptic technique. Christie also covers:
- How to choose the best locations for EM;
- Making the case to regulators for the choice;and
- Key trendsof 483 citations from FDA and EMA.
Presentation: Download the presentation
Speaker: Kenneth Christie, COO, Consulting Services at VTS Consultants Inc.
Description: Supplier management expert John Avellanet covers regulatory requirements for data management, supplier validation review,SOPs and records closeout. He answers important questions regardingthe:
- Interrelationship between 21 CFR Parts 11 and 820;
- Supplier accountability;
- FDA enforcement trends; and
- How “paper audits” can be the first foundation for a strong compliance program, and how to identify which records to retain and required SOPs.
Presentation: Download the presentation
Speaker: John Avellanet, Managing Director, Cerulean Associates LLC
Description: Two industry experts address cross-contamination from several angles. Topics covered include:
- Dedicated washrooms;
- Material sampling rooms;
- Production suites and other support rooms; and
- Air handling, engineering controls, and systems and processing, including certification to ISO standards.
Presentation #1: Download the presentation from Kevin Rosenthal
Presentation #2: Download the presentation from Stephanie Wilkins
Speakers: Kevin Rosenthal, Director of Manufacturing, Pharmatek Laboratories Inc. and Stephanie Wilkins, PE, Lean Six Sigma Green Belt
Description: Speakers Olga Marchenko and Seth Berry of Quintiles, Inc. present 10 reasons to use adaptive designs in dose-ranging studies and 10 benefits of modeling and simulation in drug development. Topics include:
- Theory and methods in adaptive design;
- Algorithm-based designs vs. model-based designs; and
- Future view of model-based design’s impact on the biopharma industry.
Presentation: Download the presentation
Speakers: Olga Marchenko, Vice President, Quintiles Inc. and Seth Berry, Director of Clinical PK-PD Modeling and Simulation, Quintiles Inc.
Marketed Unapproved Drugs
63 minutes
Description: Attorney Kurt Karst of FDA Law Blog explains how the FDA’s unapproved drug enforcement options have changed since the agency revised its Compliance Policy Guide to allow action at any time without prior notice and without regard to prior enforcement policies. To aid drugmakers, Karst presents:
- Six priority areas the FDA is pursuing;
- A decision tree for deciding whether or not a drug is considered unapproved by the FDA; and
- Exceptions to FDA policy.
Presentation: Download the presentation
Speaker: Kurt Karst, Director and Attorney, Hyman, Phelps & McNamara P.C.
Description:
Attorney Benjamin England explains how the FDA’s PREDICT program uses risk-based decisionmaking to guide its import screening efforts. England discusses:
- Differences between PREDICT and prior import screening methods;
- How PREDICT uses automated data-mining and pattern discovery, results feedback, reinforcement and recognition to target potential import violations; and
- How the program’s increased efficiency leads to more FDA enforcement actions while still expediting entry of nonviolative goods.
Presentation: Download presentation
Speaker: Benjamin L. England Esq., Founding Member, Benjamin L. England & Associates LLC