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

Recorded on: Sept. 29, 2016

Description: Operations management expert Dan O’Leary explains the fundamental requirements of medical device process validation and uses warning letters to illustrate best practices. He discusses:

  • The role of IQ, OQ and PQ in process validation;
  • Issues of parameter control, data collection and data analysis and how to apply them to production runs;
  • The QSIT inspection approach and how FDA Investigators apply it; and
  • New requirements introduced in the recently revised ISO 13485:2016.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, President, Ombu Enterprises, LLC

Recorded on: Sept. 28, 2016

Description: Sparta System’s Joe Humm discusses how companies are leveraging information for benchmarking, incorporating learnings into their business processes and making better real-time decisions. Topics include:

  • Company and market dynamics;
  • Technology solutions; and
  • Data-driven storytelling.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Joe Humm, Vice President, Global Sales Operations, Sparta System

Recorded on: Sept. 27, 2016

Description: Quality management experts Susan Schniepp and Linda Biava dig into the details of data integrity and how to detect problems. They cover:

  • Data integrity code of conduct;
  • Who is responsible for data integrity;
  • Frequency of audits; and
  • Building a culture of quality.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Susan J. Schniepp, Fellow, and Linda Biava, Regulatory Specialist, Regulatory Compliance Associates, Inc.

Recorded on: Sept. 21, 2016

Description: Law professor William Janssen provides a practical explanation of eight recent key decisions that affect what regulatory affairs does every day, in ways you may not have realized before. Cases include:

  • Amarin v. United States
  • United States v. Quality Egg
  • Caplinger v. Medtronic, Inc.
  • Yates v. Ortho-McNeil-Janssen Pharma

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: William Janssen, Professor of Law, Charleston School of Law

Recorded on: Sept. 14, 2016

Description: Attorneys Stacy Ehrlich and Will Woodlee explain what OTC drug products require premarket approval, labeling and promotion rules, and common but avoidable mistakes in marketing OTC drug products. They discuss:

  • How the FDA determines whether it will regulate a product as a drug and whether the drug must be dispensed only with a healthcare provider’s prescription;
  • The difference between OTC drug labeling and advertising, and who regulates the content of these materials; and
  • What needs to appear on OTC drug labeling and the common mistakes made by industry.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Stacy Ehrlich and Will Woodlee, Partners, Kleinfeld, Kaplan & Becker, LLP

Recorded on: Sept. 7, 2016

Description: International pediatric research expert Martine Dehlinger-Kremer explains the pediatric clinical trials regulations drugmakers need to understand when they begin development of a new product. She covers:

  • The impact of deferrals and waivers to planned pediatric clinical trial requests;
  • Technical requirements for pediatric clinical trials mandated by the International Council on Harmonization and the EWG Working Group; and
  • How to streamline paperwork on pediatric clinical trials in conjunction with the recently implemented guideline on pediatric study plans.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Martine Dehlinger-Kremer, Global Vice President, Medical & Regulatory Affairs, SynteractHCR

Recorded on: Aug. 31, 2016

Description: Computer system validation expert David Harrison discusses best practices and available options for validating spreadsheets, including:

  • Exactly what the FDA looks for and why;
  • Spreadsheet validation "gaps" the FDA is targeting;
  • How to generate spreadsheet specifications and qualification protocols; and
  • How to test spreadsheets and macros.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: David Harrison, Principal Consultant, CSV Compliance Limited

Recorded on: Aug. 30, 2016

Description: China regulatory expert John Balzano provides an analytical introduction to China’s medical device regulations including GMPS, self-inspections, foreign inspections and enforcement trends and requirements for importing devices. He discusses:

  • Implementation of the new GMPs, including the procedural rules for inspections, preparation, communicating with inspectors, resolving issues and potential penalties;
  • Transfer of manufacturing sites and amendment of manufacturing and device licenses;
  • Policies and rules on contract manufacturing for medical devices; and
  • Handling self-inspections and evaluations of past compliance.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: John Balzano, Special Counsel, Covington and Burling, LLP

Recorded on: Aug. 18, 2016

Description: Quality systems and operations expert Dan O’Leary outlines the revisions made to ISO 13485 and discusses transitioning to the new certification requirements. He covers:

  • Potential conflicts with the Quality System Regulation;
  • The role of ISO 13485:2016 in the Medical Device Single Audit Program and Canada’s plan to adopt it; and
  • The transition plan for the EU Harmonized Standard.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O'Leary, President, Ombu Enterprises, LLC

Recorded on: Aug. 17, 2016

Description: Regulatory experts John O’Brien and Christopher Ripple discuss some of the practical considerations to take into account when drafting and documenting an FSMA-compliant food defense plan. Topics include:

  • Key distinctions between the Food Defense Rule and the Hazard Analysis and Critical Control Points (HAACP) and Hazard Analysis and Risk-Based Preventive Controls (HARPC) analyses;
  • Unresolved issues and challenges; and
  • Why the Food Defense Rule requires significant education and outreach.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: John F. O’Brien III, Counsel, and Christopher A. Ripple, Associate, McGuireWoods LLP