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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
Description: Industry expert Dean Calhoun covers the landscape of regulator and patient issues, with special focus on the best tools to assess and mitigate risk, including:
- Failure Mode and Effects Analysis;
- Fault Tree Analysis; and
- HAZOP
Presentation: Download the presentation
Speaker: Dean Calhoun, President, Affygility Solutions
Description: European legal experts Peter Bogaert and Francois-Regis Babinet outline proposed revisions to EU medical device regulations, including:
- Classification in four classes: A (lowest risk) to D (highest risk);
- Expanded scope to cover software and genetic tests; and
- Mandatory publication of summary of key safety and performance clinical data.
Presentation: Download the presentation
Speakers: Peter Bogaert, Managing Partner, Brussels Office of Covington & Burling and François-Régis Babinet, Associate, Brussels Office of Covington & Burling
Description: Legal expert Afia Asamoah outlines the most important and complex elements of clinical investigator financial disclosure requirements. Topics include:
- How and what information to collect;
- How to document and otherwise handle a change in sponsor; and
- Accounting for an investigator’s family.
Presentation: Download the presentation
Speaker: Afia Asamoah, Attorney, Covington & Burling
Combination Products cGMP Final Rule
94 minutes
Description: Former FDA official Suzanne O’Shea interprets the agency’s combination products cGMP final rule, including:
- Single entity and co-packaged combinations;
- How to comply with both drug and device regulations and which takes precedence; and
- How the rule applies to investigational products.
Presentation: Download the presentation
Speaker: Suzanne O'Shea, J.D., Counsel, Faegre Baker Daniels
Medical Device Excise Tax
87 minutes
Description: Tax expert Dan Lynn offers detailed insights into the provisions of the medical device excise tax, including:
- How documentation with respect to each product should be maintained;
- Exemptions from the tax; and
- Proper application of the law will likely require coordination between purchasers and sellers of taxable devices (export and further manufacture).
Presentation: Download the presentation
Speaker: Dan Lynn, CPA, MBA, Tax Partner, Beene Garter
Description: Legal experts Laurie Clarke and Lynette Zentgraft provide an overview of three important 510(k)-related guidances designed to make review of premarket submissions more efficient. Topics include:
- Definition of “eCopy;”
- Changes in acceptance review checklists for 510(k)s; and
- Acceptance decision timelines.
Presentation: Download the presentation
Speakers: Laurie Clarke, Partner, King & Spalding’s FDA & Life Sciences Practice Group and Lynette Zentgraft, Senior Regulatory Consultant, King & Spalding’s FDA & Life Sciences Practice Group
Description: Legal analysts David Charapp and Erin Duffy highlight the most important reporting provisions when handling reimbursement for subject injuries in clinical trials, including:
- Determining whether a claimant (including an individual whose claim is unresolved) is entitled to Medicare;
- Submitting claimant information in the manner, form and frequency required by the FDA; and
- Penalties for failing to comply.
Presentation: Download the presentation
Speakers: David A. Charapp, Partner, Duane Morris LLP and Erin M. Duffy, Associate, Duane Morris LLP
eCTD Requirements
78 minutes
Description: Industry esubmissions leader Antoinette Azevedo examines key factors in preparing electronic common technical documents (eCTD) under FDASIA, including:
- Building a technology knowledge base;
- Requiring CROs and CMOs to supply searchable PDF reports compliant with FDA specifications; and
- Using a process and checklists to verify that submission is complete and accurate.
Presentation: Download the presentation
Speaker: Antoinette Azevedo, Principal, e-SubmissionsSolutions.com
Description: Consultant Kenneth Christie explains the most important aspects of developing and maintaining a compliant program, with a special emphasis on cleaning. He also provides insights on what the FDA expects of such a program, including:
- Establishment of schedules for frequency;
- Establishment of defined procedures and methods to be used;
- Documentation of results; and
- Evaluation of deviations on equipment or product.
Presentation: Download the presentation
Speaker: Kenneth Christie, COO, Consulting Services at VTS Consultants Inc.
QSRs 820.20 - Management Responsibility
91 minutes
Description: Industry analyst Dan O’Leary discusses why management with executive authority has the responsibility to create and maintain a Quality Management System. He also addresses other important QMS components, including:
- Quality policy and quality objectives;
- Proper organization and adequate resources; and
- A management representative to oversee the QMS.
Presentation: Download the presentation
Speaker: Dan O’Leary, President, Ombu Enterprises LLC