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: 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,

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.

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

Description: Legal experts Keith Korenchuk and Samuel Witten dissect the FCPA and clarify its contents. The webinar also covers how to meet its recordkeeping requirements, including:
  • Devising and maintaining a system of internal accounting controls sufficient to provide reasonable assurances that transactions are properly authorized and all amounts are recorded accurately;
  • Understanding that the recordkeeping requirements cover all payments, not just those that would be “material” under other accounting requirements; and
  • How a company can be in violation of the FCPA’s recordkeeping requirements even if it did not intend to break the law or to keep inaccurate books and records.

Presentation: Download the presentation

Speakers: Keith Korenchuk, Partner, Arnold & Porter, LLP and Samuel Witten, Counsel, Arnold & Porter, LLP

Description: Compliance expert Barbara Godlew explains how to develop an institutional/company policy on trial data disclosure and how to create effective SOPs. Other hands-on practical tips include how to:
  • Consider software for creating/routing/uploading disclosure records;
  • Verify new informed consent letters for applicable clinical trials; and
  • Adjust compliance strategies for international trials for which the researcher is the sponsor/responsible party.

Presentation: Download the presentation

Speaker: Barbara Godlew, RN, BA, President, The FAIRE Company, LLC

Description: Attorney James Wood explains how the FDA views potential recall scenarios and how it differentiates between a recall situation and a less serious clarification. Wood identifies what should be in a recall report and how to present that information, including:
  • Number of consignees notified of the recall, and date and method of notification;
  • Number of consignees responding to the recall communication and quantity of products on hand at the time it was received;
  • Number of consignees that did not respond; and
  • Number of products returned or corrected by each consignee contacted and the quantity of products accounted for.

Presentation: Download the presentation

Speaker: James M. Wood, Attorney, Reed Smith

Description: Legal expert Darshan Kulkarni delivers an anaylsis of FDA enforcement trends aimed at IRBs, CROs, sponsors and sites. Topics include:
  • The ins and outs of when to respond;
  • When not to respond; and
  • What evidence is most effective with the FDA.

Presentation: Download the presentation

Speaker: Dr. Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm

Description: Industry expert Debbie Wilkerson provides in-depth analysis of approval process enforcement actions and device recalls. She also focuses on the four key elements of study design:
  • Retrospective Case-Control;
  • Retrospective Cohort;
  • Crossover; and
  • Randomized Control Trials.

Presentation: Download the presentation

Speaker: Dr. Debbie Wilkerson, Clinical Research Director, Medtronic Spinal