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 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

Description: Legal authority Darshan Kulkarni outlines a strategy for springing into fast action with an inspection “war room” that can address any issue. Kulkarni covers:
  • Roles and responsibilities for personnel involved in inspections;
  • How to greet inspectors and assemble the war room team; and
  • When to call on outside experts for help.

Presentation: Download the presentation

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

Description: A well-rounded team of experts demonstrates why flawed adverse event reporting and labeling have contributed to a suicide epidemic worldwide, putting patients and pharmaceutical companies at increased risk. After offering an overview of the current landscape and weaknesses in key programs, the team provides potential solutions, including:
  • Intervention trials using prospective and systematic measurement of suicidality that more clearly delineate the relationship between suicidal adverse events and medication treatment;
  • Consistent and systematic assessment that provide more meaningful data within a study, as well as across studies, improving pooled analyses;
  • Understanding that decreasing false positives and debunking false notions of risk are as important as knowing about risks that exist; and
  • Including suicidal subjects in trials to increase generalizability and avoid unnecessary exclusions.

Presentation #1: Download the presentation from Dr. Kelly Posner

Presentation #2: Download the presentation from Dr. John Greist

Speakers: Dr. Kelly Posner, Founder, Center for Suicide Risk Assessment at Columbia University/New York State Psychiatric Institute; Dr. John Greist, CEO, Healthcare Technology Systems and Mike Federico, Vice President, ePRO solutions, ERT Inc.

Description: Informed consent consultants Susan Brink and Sherry Bracy elucidate the benefits of electronic informed consent programs and offer an insider’s vendor evaluation process, including the answers firms should look for. Questions to ask include:
  • How is system access controlled?
  • Is there a robust back-up process?
  • What is the process for sites if the system is down or the Internet is not available at the time you are obtaining consent from a patient?

Presentation: Download the presentation

Speakers: Dr. Susan Brink, President and CEO, Consent Solutions Inc. and Sherri Bracy, Founder and Director, Bracy Consulting LLC.

Description: Expert David Vogel outlines FDA recall enforcement trends, and the most common shortcomings in device company recall programs. He also spotlights some less obvious device company recall program weaknesses, including:
  • Why large software modules more likely to fail;
  • How to assess the amount,  quality of testing;
  • How to assess the skill and experience level of a designer – when to put the best designers on the most critical software; and
  • How to assess the skill and experience level of testers.

Presentation: Download the presentation

Speaker: Dr. David Vogel, Founder, Intertech Engineering Associates