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
- Failure Mode and Effects Analysis;
- Fault Tree Analysis; and
- HAZOP
Presentation: Download the presentation
Speaker: Dean Calhoun, President, Affygility Solutions
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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