![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
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.
BUY NOW Single-User 1-Year Unlimited Access $1,362
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.
Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact Russ Titsch, Business Development Director at russ.titsch@wcgclinical.com or +1 703.538.7651 to receive a custom quote.
Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.
Webinar Training Pass
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
QSR Data and Trending
74 minutes
Description: An overlooked requirement within the Quality System Regulation (QSR) is quickly moving up the audit checklist of FDA investigators. QSR Section 820 doesn’t mention the word “trend,” but the FDA has demonstrated in 483s and warning letters that it expects companies to analyze and trend their quality data — and then act on what they’ve learned. But most companies don’t know the scope of the requirements, let alone how to react to them. Is yours one of them?
Presentation: Download presentation
Speaker: James Eric Miller, Core Quality Systems Senior Quality Analyst, Roche Diagnostics
Clinical Trial Billing Under Medicare
96 minutes
Description: Kevin Eskew and Lisa Murtha of SNR Denton Healthcare Group discuss the impact of Medicare policies on clinical trial billing and explain how to negotiate a clinical trial budget that keeps your sites operating and billing in compliance. Information presented includes:
- Which costs are billable to third-party payers;
- Strategies for managing billing and risk reduction; and
- Requiring development and use of Medicare Coverage Analysis at the beginning of the planning stage.
Presentation: Download presentation
Speakers: Kevin R. Eskew, Managing Director, SNR Denton Health Care Group and Lisa Murtha Esq., Member, Sonnenschein Health Care Group