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.

Already have an account?   Login Here.

Webinar Training Pass

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

Description: Industry expert Brian Dense assesses the strengths and weaknesses of off-the-shelf quality systems against custom solutions, providing real-world case studies that highlight the best and worst of each approach. He also focuses on avoiding several common errors when choosing the best approach, including:
  • Misunderstanding the purpose of a quality system;
  • Misunderstanding regulatory requirements of the market; and
  • Failing to understand that quality is a department, not an integrated practice.

Presentation: Download the presentation

Speaker: Brian Dense, President, CiNQ Systems

Description: SOP analysts Steven Steinbrueck and Elizabeth Bodi share ways to shorten and focus SOPs, demonstrating how to spot and prevent common mistakes, including:
  • Dictating how to accomplish a task;
  • Mandating dates; and
  • Including things that are not regulatory requirements/expectations, senior management mandates or accepted best practices.

Presentation: Download the presentation

Speakers: Steven Steinbrueck, President, Stonebridge GCP Consulting and Elizabeth Bodi, Clinical Research Senior Consultant, Halloran Consulting Group

Description: Industry analyst Thomas Peither covers important ground on the many changes to EMA drug process validation. Peither discusses:
  • Why validation should be carried out in accordance with GMP;
  • The need for a minimum of 3 validation batches; and
  • Basing the number of batches on the variability of the process, the complexity of the process/product, and the experience of the manufacturer

Presentation: Download the presentation

Handout #1: Synopsis: FDA Process Validation Guidance

Handout #2: Guidance for Industry, Process Validation: General Principles and Practices

Handout #3: Note for Guidance on Process Validation

Handout #4: European Medicines Agency: Draft Guideline on Process Validation

Handout #5: Comparison Between EMA and FDA On Traditional Process Validation Approaches

Speaker: Thomas Peither, President, Maas & Peither America Inc.