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: International law experts Michael Burke and Ed Cadagin outline misconceptions and red flags that can lead to Foreign Corrupt Practices Act violations. Topics include:

  • Recent changes to FCPA enforcement that impact life sciences companies;
  • Supply-chain vulnerabilities; and
  • Managing an effective FCPA compliance program.

Presentation: Download the presentation

Speakers: Michael Burke, Corporate Practice Partner, and Ed Cadagin, Litigation and Employment Practice Associate, Arnall Golden Gregory LLP

Description: Quality management analyst Matthew Littlefield teaches how to build a business case for a quality solution, make key decisions based on a company's maturity, and gain insight into the benefits of adopting applications that focus on quality and compliance. Topics include:

  • Major trends impacting the life sciences industry;
  • Next generation quality management solutions; and
  • Closed-loop quality management.

Presentation: Download the presentation

Speaker: Matthew Littlefield, President, LNS Research

Description: Noted UDI authorities Dan O'Leary and Don Guthner present a model to help companies understand the time restraints and requirements they are under with the new UDI/GUDID legislation. Topics include:

  • Locating and loading data;
  • Understanding the concepts of data integrity and Part 11; and
  • Quality system changes.

Presentation: Download the presentation

Handouts: Download the presentation

Speakers: Dan O'Leary, President, Ombu Enterprises, LLC; Don Guthner, Founder and Principle of Orgenix, LLC

Description: Clinical operations specialists Sherri Hubby and Brian Nugent present the essential building blocks of an effective Quality by Design system for clinical trials. Topics include:

  • Reducing variability of process and data collection methods;
  • Maintaining consistent process attributes and parameters;
  • Risk assessment and monitoring.

Presentation #1: Download the presentation

Presentation #2: Download the presentation

Speakers: Sherri Hubby, U.S. Director of Quality Assurance, Premier Research; Brian Nugent, Associate Director of Clinical Operations, Gilead Sciences

Description: Import specialist Ben England explains U.S. Customs operational processes and offers tips for strengthening compliance and avoiding import holds. He covers:

  • How to minimize risk of delays, detentions and refusals;
  • How to work with suppliers, contractors and labelers; and
  • Conducting a gap analysis to identify import program weaknesses.

Presentation: Download the presentation

Speaker: Ben England, CEO, FDAImports.com

Description: Laboratory compliance expert Ludwig Huber presents a laboratory equipment qualification primer that walks the user through the process step by step. He covers:

  • Essential steps for laboratory equipment qualification;
  • How to effectively qualify existing nonqualified equipment for use in regulated areas; and
  • How to write a qualification report.

Presentation: Download the presentation

Speaker: Ludwig Huber, Ph.D., Director, Labcompliance

Description: Industry experts Kevin Nelson and Patrick Gallagher use real-world examples of companies currently attempting to demonstrate biosimilarity and demonstrate best practices that allow sponsors to use the FDA's recent draft guidance to improve their chances of getting 351(k) biosimilar applications approved. Topics include:

  • How FDA's thinking on the clinical requirements for showing biosimilarity has begun to evolve with the 2014 clinical guidance;
  • Preparing an approvable 351(k) application through the use of the Biological Product Development Program; and
  • How to use the inter partes review (IPR) process to tackle patent barriers and lessen your patent litigation budget.

Presentation: Download the presentation

Speakers: Kevin Nelson, Partner, and Patrick Gallagher, Associate, Intellectual Property Practice Group, Duane Morris LLP

Description: Drug-naming expert Dr. Susan Proulx addresses industry concerns about FDA drug-naming guidance and discusses best practices for naming drugs to help assure FDA approval. Topics include:

  • Pros and cons of relying on computerized searching to identify similarity in proposed names;
  • Using simulation testing to predict FDA reaction to a drug name; and
  • The need for expert analysis prior to deciding what trademark to choose.

Presentation: Download the presentation

Handout: Download the handout

Speakers: Susan Proulx, PharmD, President, Med-ERRS, Inc.

Description: Using real-life examples, loss control expert Sara Dyson shows how others have handled liability issues related to off-label promotion, explaining what they did right and where they went wrong. Topics include:

  • What off-label use and promotion is and how to avoid it;
  • Products liability causes of action related to off-label promotion; and
  • Two major defenses against liability that are undercut by off-label promotion

Presentation: Download the presentation

Speaker: Sara Dyson, Assistant Vice President of Loss Control, Medmarc Insurance Group

Description: ANDA expert Andy Papas teaches how to achieve first-pass approvals for new generic drug products. Topics include:

  • What impact GDUFA is having on today's ANDA applications and how sponsors should be responding;
  • How to assure you've adequately addressed bioequivalence requirements ahead of time; and
  • Key considerations to address FDA-identified completeness, quality, and bioequivalence issues.

Presentation: Download the presentation

Speaker: Andy Papas, Vice President of Regulatory Affairs at NSF Health Sciences Pharma Biotech