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: In this webinar, legal analyst Ed Dougherty shows how to:
  • Develop a single, integrated regulatory/market access strategy and point of contact;
  • Conduct an early landscape assessment to develop a milestone-driven strategic plan; and
  • Create a new gap analysis technique to evaluate assets, determine what to leverage and what to build; and
  • Update a reimbursement strategy to anticipate new market dynamics.

Presentation: Download the presentation

Speaker: Ed Dougherty, Senior Healthcare Advisor, Arent Fox

Description: Regulatory experts James Ravitz and Stephanie Trunk dissect regulations governing off-label promotion. Topics covered include:
  • Key areas of risk and potential red flags;
  • Responding to public and non-public unsolicited requests for information;
  • Implications of the responsible corporate officer doctrine; and
  • How a violation becomes a false claims case.

Presentation: Download the presentation

Speakers: James Ravitz, Partner, Arent Fox LLP and Stephanie Trunk, Associate in the Health Law Group, Arent Fox LLP

Description: Leading legal analysts Erika Lietzen and Laura Sim deconstruct the FDA’s biosimilars guidance and the comments it received and what FDA enforcement and emphasis might look like in the future.  They also highlight important areas the guidance doesn’t address, such as:
  • Pediatric testing; and
  • When a regulated entity should construct its own defensible compliance programs instead of waiting for overt FDA direction.

Presentation: Download the presentation

Speakers: Erika Lietzen, Partner, Covington & Burling and Laura Sim, Associate in Food & Drug practice group, Covington & Burling

Description: A trio of legal experts guides devicemakers through the 510(k) process, focusing on:
  • How to better understand and produce  compliant 510(k) content;
  • How to handle a predicate event; and
  • How to understand when a regulated entity should issue a 510(k).

Presentation: Download the presentation

Speakers: Neil O'Flaherty, Principal, Olsson Frank Weeda Terman Matz PC (OFW Law); Evan Phelps, Principal, OFW Law and Nancy Mathewson, Associate, OFW Law

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