The Webinar Training Pass

Now get all the training you need – all in one place, and all for one low price!

The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.

PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!

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.

Select webinars have been pre-approved by RAPS as eligible for up to 1.5 credits toward a participant’s RAC recertification. Please enter keyword RAPS below for a list of eligible on-demand webinars.

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Webinar Training Pass

Description: Industry expert Dan O’Leary analyzes FDA warning letters to demonstrate how understanding the agency’s enforcement emphasis can help inform a robust acceptance program. O’Leary provides insight on:
  • Definition of key terms;
  • How to understand and leverage sampling plans; and
  • How to adequately respond to an FDA warning letter.

Presentation: Download the presentation

Handout: Download Checklist for acceptance activities

Speaker: Dan O’Leary, President, Ombu Enterprises LLC

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

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

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.