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: Regulatory compliance expert Gordon Richman discusses how to handle recalls under Part 806 of the Quality System Regulations. Richman focuses on:
  • Key differences between Parts 7 and 806 when it comes to device recall strategy;
  • Unique challenges to accurate reportability; and
  • Ways to evaluate the proper recall criteria for a devicemaker.

Presentation: Download the presentation

Handout: 21 CFR Part 806 Process Flow

Speaker: Gordon B. Richman, Vice President, Strategic Compliance Consulting and General Counsel, EduQuest

Description: Consultants Dean Cirotta and William Ment cite the most common GMP deficiencies found in dietary supplement manufacturing and the best way to handle FDA inspections. This presentation provides:
  • An overview of FDA inspections and regulatory actions;
  • Review of the FDA’s compliance program for dietary supplements;
  • What the agency considers the major deviations that often result in warning letters; and
  • Strategies for responding to warning letters and 483s.

Presentation: Download the presentation

Speakers: Dean Cirotta, Vice President, EAS Consulting Group and William Ment, Contract Consultant, EAS Consulting Group

Description: Susan Reilly, a long-time consultant on medical device complaint management issues, offers a clearer understanding of how to handle complaints.  She discusses:
  • The essential components of a complaint management system;
  • How to handle failure investigations; and
  • Adverse event evaluation and recordkeeping.

Presentation: Download the presentation

Speaker: Susan Reilly, Owner and Principal Consultant, Reilly & Associates LLC

Description: Environmental monitoring expert Kenneth Christie provides explanations of regulatory requirements for EM programs, facility design, personnel training and aseptic technique. Christie also covers:
  • How to choose the best locations for EM;
  • Making the case to regulators for the choice;and
  • Key trendsof 483 citations from FDA and EMA.

Presentation: Download the presentation

Speaker: Kenneth Christie, COO, Consulting Services at VTS Consultants Inc.

Description: Supplier management expert John Avellanet covers regulatory requirements for data management, supplier validation review,SOPs and records closeout. He answers important questions regardingthe:

  • Interrelationship between 21 CFR Parts 11 and 820;
  • Supplier accountability;
  • FDA enforcement trends; and
  • How “paper audits” can be the first foundation for a strong compliance program, and how to identify which records to retain and required SOPs.

Presentation: Download the presentation

Speaker: John Avellanet, Managing Director, Cerulean Associates LLC

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