The Webinar Training Pass

The 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.

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.

Many of our 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: Two industry experts address cross-contamination from several angles. Topics covered include:
  • Dedicated washrooms;
  • Material sampling rooms;
  • Production suites and other support rooms; and
  • Air handling, engineering controls, and systems and processing, including certification to ISO standards.

Presentation #1: Download the presentation from Kevin Rosenthal

Presentation #2: Download the presentation from Stephanie Wilkins

Speakers: Kevin Rosenthal, Director of Manufacturing, Pharmatek Laboratories Inc. and Stephanie Wilkins, PE, Lean Six Sigma Green Belt

Description: Speakers Olga Marchenko and Seth Berry of Quintiles, Inc. present 10 reasons to use adaptive designs in dose-ranging studies and 10 benefits of modeling and simulation in drug development. Topics include:
  • Theory and methods in adaptive design;
  • Algorithm-based designs vs. model-based designs; and
  • Future view of model-based design’s impact on the biopharma industry.

Presentation: Download the presentation

Speakers: Olga Marchenko, Vice President, Quintiles Inc. and Seth Berry, Director of Clinical PK-PD Modeling and Simulation, Quintiles Inc.

Description: Attorney Kurt Karst of FDA Law Blog explains how the FDA’s unapproved drug enforcement options have changed since the agency revised its Compliance Policy Guide to allow action at any time without prior notice and without regard to prior enforcement policies. To aid drugmakers, Karst presents:
  • Six priority areas the FDA is pursuing;
  • A decision tree for deciding whether or not a drug is considered unapproved by the FDA; and
  • Exceptions to FDA policy.

Presentation: Download the presentation

Speaker: Kurt Karst, Director and Attorney, Hyman, Phelps & McNamara P.C.

Description: Attorney Benjamin England explains how the FDA’s PREDICT program uses risk-based decisionmaking to guide its import screening efforts. England discusses:
  • Differences between PREDICT and prior import screening methods;
  •  How PREDICT uses automated data-mining and pattern discovery, results feedback, reinforcement and recognition to target potential import violations; and
  • How the program’s increased efficiency leads to more FDA enforcement actions while still expediting entry of nonviolative goods.

Presentation: Download presentation

Speaker: Benjamin L. England Esq., Founding Member, Benjamin L. England & Associates LLC

Description: An overlooked requirement within the Quality System Regulation (QSR) is quickly moving up the audit checklist of FDA investigators. QSR Section 820 doesn’t mention the word “trend,” but the FDA has demonstrated in 483s and warning letters that it expects companies to analyze and trend their quality data — and then act on what they’ve learned. But most companies don’t know the scope of the requirements, let alone how to react to them. Is yours one of them?

Presentation: Download presentation

Speaker: James Eric Miller, Core Quality Systems Senior Quality Analyst, Roche Diagnostics

Description: Kevin Eskew and Lisa Murtha of SNR Denton Healthcare Group discuss the impact of Medicare policies on clinical trial billing and explain how to negotiate a clinical trial budget that keeps your sites operating and billing in compliance. Information presented includes:

  • Which costs are billable to third-party payers;
  • Strategies for managing billing and risk reduction; and
  • Requiring development and use of Medicare Coverage Analysis at the beginning of the planning stage.

Presentation: Download presentation

Speakers: Kevin R. Eskew, Managing Director, SNR Denton Health Care Group and Lisa Murtha Esq., Member, Sonnenschein Health Care Group

Description: Graeme Ladds, CEO of PharSafer Associates Ltd., explains requirements for electronic submission of Individual Case Safety Reports (ICSR), both in Europe and in the U.S., including:
  • Who should report and to whom?
  • What information should be reported;
  • Exemptions for “exceptional circumstances;” and
  • How to report follow-up information.

Presentation: Download presentation

Speaker: Graeme Ladds, CEO, PharSafer Associates Ltd.

Description: Einar Bjornsson, Professer of Gastroenterology and Hepatology at Landspitali University Hospital, explains how to use data capture methods to minimize drug-induced livery injury risks without risking patients. He covers:
  • When DILI is most likely to occur;
  • Drug factors in DILI outcomes;
  • Phase I vs. Phase II reactions; and
  • A comparison of compounds with significant and nonsignificant hepatic metabolism.

Presentation: Download presentation

Speaker: Einar Bjornsson, Professor of Gastroenterology and Hepatology, Landspitali University Hospital

Description: Josh Feldstein of the Center for Applied Value Analysis makes the case for using comparative cost effectiveness (CCE) research and value analytic models to help demonstrate a product’s value to purchasing decisionmakers. Feldstein discusses:
  • Training needed to conduct effective CCE research;
  • Learning from programs already in use in the EU, Canada and Australia;and
  • Integrating medical statistics and health economics to create a value analytic model.

Presentation: Download presentation

Speaker: Josh Feldstein, President, Joint Center for Applied Value Analysis and Principal, MarCom Group International

Description: Attorney Chad Landmon presents strategies for achieving FDA approval of an ANDA by using Paragraph IV certification instead of costly and lengthy patent litigation. Landmon covers such topics as:
  • Understanding the FDA’s bioequivalence requirements;
  • How to craft an ANDA that directly addresses the patent infringement issue; and
  • Strategies for addressing exclusivity grants.

Presentation: Download presentation

Speaker: Chad Landmon Esq., Partner, Axinn Veltrop & Harkrider LLP