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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.
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
Observational Studies
83 minutes
Recorded on: Sept. 6, 2017
Description: Health economics and outcomes specialist Jeff Trotter explains the opportunities and pitfalls of using observational studies to show evidence of product safety and efficacy and discusses the impact of the 21st Century Cures Act. He covers:
- The critical link between strategy and operational efficiency in observational studies;
- Setting internal and external expectations for real-world evidence; and
- Best practices for ensuring clinical and commercial collaboration in support of observational studies and patient registries.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jeff Trotter, President, Continuum Clinical
Implementing Elemental Impurities Testing
76 minutes
Recorded on: Aug. 31, 2017
Description: Regulatory expert Wayland Rushing explains the requirements of ICH guidance Q3D on elemental impurities in drug products. He covers:
- Comparison of ICH Q3D vs. USP requirements;
- Risk assessment and gathering information from suppliers;
- Analytical strategies and techniques; and
- Challenges associated with testing.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Wayland Rushing, Director of Scientific Affairs, EAG Labs
Recorded on: Aug. 24, 2017
Description: Quality systems expert Dan O’Leary analyzes the FDA’s two guidances on cybersecurity for medical devices. He covers:
- A design control framework for cybersecurity;
- The role of software verification and validation in cybersecurity;
- Identifying expected cybersecurity documents in the design history file; and
- Postmarket information, sources, and effect on cybersecurity.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: Aug. 22, 2017
Description: Biologics experts Suzanne Sensabaugh and Nitisha Pyndia explain the FDA’s view of interchangeability in biosimilars. They discuss:
- The most challenging areas of product development — including technical issues of similarity in purity and potency — and how to comply;
- How the FDA evaluates immunogenicity, a key factor entailing communication and cooperation with scientific colleagues;
- The chemistry of structural features; and
- Understanding the differences between interchangeability and biosimilarity.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Suzanne M. Sensabaugh, President and Principal Consultant, and Nitisha Pyndiah, Consultant, HartmannWillner
Design Controls for Combination Products
88 minutes
Recorded on: Aug. 15, 2017
Description: Former director of the FDA Investigations Branch Ricki Chase explains FDA’s GMP guidance for combination products, focusing on the often-overlooked topic of design control. She discusses:
- How design controls apply to combination products, including biologic/device and drug/device combinations;
- How already available information can help speed new products to market; and
- Using human factor studies to support combination product submissions.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ricki Chase, Director, Lachman Consultant Services, Inc.
Recorded on: Aug. 14, 2017
Description: FDA regulatory expert Jim O’Reilly discusses how the FDA plans to implement the variety of provisions in the 21st Century Cures Act and how those plans will affect manufacturers. He covers:
- How the FDA Science Board's new standards can lead to much faster product development approvals;
- How the FDA will allocate the $500 million authorized by Congress; and
- The role of the agency’s new Office of Translational Sciences, which governs the bench-to-clinical process.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jim O’Reilly, Professor, University of Cincinnati College of Medicine
CDRH’s New Culture of Quality Initiative
77 minutes
Recorded on: Aug. 9, 2017
Description: CDRH officials Francisco Vicenty and Daniel Walter discuss the center’s new Culture of Quality program, its goals and how it will affect inspections. They cover:
- The disconnect between compliance and quality;
- New metrics for evaluating device quality;
- Accelerated approval of premarket submissions; and
- CDRH’s new voluntary pilot program for devicemakers to help the center identify quality indicators.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Michael Gaba, Shareholder, Polsinelli LLP; Francisco Vicenty, Program Manager for the Case for Quality, Office of Compliance, Center for Devices and Radiological Health; and Daniel Walter, Chief of the Foreign Enforcement Branch, Division of International Compliance Operations, CDRH
ClinicalTrials.gov and the New Final Rule
90 minutes
Recorded on: Aug. 2, 2017
Description: Regulatory lawyer Scott Cunningham interprets the new final rule on clinical trial registration, 42 CFR Part 11. He discusses:
- The four elements of an “applicable drug clinical trial,” and how the FDA will interpret what these words really mean;
- Who must submit clinical trial results to ClinicalTrials.gov;
- What the FDA can do to police noncompliance and when enforcement might start; and
- Deciphering the ClinicalTrials.gov voluntary submissions provisions.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Scott Cunningham, Partner, Covington & Burling
Recorded on: July 27, 2017
Description: Regulatory experts Lisa Dwyer and Heather Bañuelos discuss the FDA’s three guidances covering medical product communications. Topics include:
- What “consistent communications” means v. on-label and off-label communications;
- How the FDA interprets the “three factor test” for consistent communications and how to apply it in practice;
- How to evaluate consistent communications as “scientifically appropriate and statistically sound;” and
- The real-life scope of the new safe harbor for pre-approval communications with payors.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Lisa M. Dwyer, Partner, and Heather Bañuelos, Counsel, King & Spalding
Disinfectant Testing and Validation
91 minutes
Recorded on: July 26, 2017
Description: Microbial control expert Jim Polarine lays out the problems facing manufacturers plus state-of-the-art solutions. He discusses:
- Proven ways to limit cleanroom contamination from incoming items;
- Proper cleanroom design and condition;
- Best products to control bacterial and mold spores; and
- Current sporicide and disinfectant regulations in the U.S. and the E.U.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jim Polarine, Senior Technical Service Manager, STERIS Corporation