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: July 27, 2016

Description: Quality systems expert Susan Reilly explains how using the Medical Device Single Audit Program model in your internal audits to make sure you meet international regulators’ requirements. She discusses:

  • How to identify and understand the MDSAP requirements as interpreted by the various regulatory authorities;
  • How to determine gaps in your current documentation; and
  • How to “score" your current quality system.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Susan Reilly, President & Principal Consultant, Reilly Associates LLC

Recorded on: July 26, 2016

Description: Regulatory expert Gordon Richman discusses how to craft effective, timely responses needed to keep 483s from escalating into warning letters and warning letters into serious trouble. He covers:

  • Techniques to successfully respond to Form 483s in 15 days or less;
  • How to evaluate the intent of the observation; and
  • What the FDA expects when reviewing Form 483 and warning letter responses.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Gordon B. Richman, Vice President and Regulatory Compliance Counsel, Danaher Diagnostics Platform at Beckman Coulter

Recorded on: July 21, 2016

Description: Medical device regulations expert Dan O’Leary explains MDR issues and provides advice on implementing an effective MDR system. He covers:

  • The required content of MDR procedures;
  • The reporting criteria for an MDR;
  • The connection between complaints and medical device reports; and
  • Auditing the MDR process.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: July 20, 2016

Description: Supplier development specialist David Parkin explains how to manage your supplier network and avoid obstacles that can make it or break it. Topics include:

  • Best practices for prioritizing your supplier control approach that will work for large or small companies;
  • How to manage your supplier controls over the long haul to create good business relationships and assure FDA compliance; and
  • What motivates a supplier to do business with you.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: David Parkin, Supplier Development Manager, Boston Scientific

Recorded on: July 19, 2016

Description: Three noted medical device regulatory experts explain upcoming changes to EU medical device reporting regulations and outline a path to compliance. They cover:

  • The current state of the legislation and political developments;
  • Areas of greatest risk and opportunity; and
  • How companies can assess their readiness and prepare for compliance.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Minnie Baylor-Henry, Strategic Advisor and Medical Device Lead, YourEncore; Judith Meritz, Strategic Advisor and member of Medical Devices Practice, YourEncore; and Jon Lange, Principal in the Advisory Services practice and EU MDR lead, Ernst & Young

Recorded on: July 12, 2016

Description: Regulatory expert Bradley Merrill Thompson outlines the opportunities and pitfalls of using social media to promote products. He covers:

  • Misbranding and false labeling;
  • Native advertising;
  • User-generated content; and
  • Status of FDA regulation.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Bradley Merrill Thompson, Member, Epstein, Becker & Green

Recorded on: June 30, 2016

Description: From his unique perspective as a member of the ISO working group that drafted the new ISO 9001: 2015, Eamonn Hoxey explains changes and new requirements found in the 2015 revision. He discusses:

  • How the revision of ISO 9001 can impact healthcare industries;
  • New requirements for defining objectives;
  • How to accommodate the ground-breaking replacement of the term “preventive action” with “risk management;” and
  • How to revise your program to comply with ISO 13845 requirements related to 9001.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Eamonn Hoxey, Vice President of Medical Devices Quality & Regulatory Compliance — Strategic Programs, Johnson & Johnson; and Tom Middleton, Solutions Architect, Sparta Systems

Recorded on: June 29, 2016

Description: Quality assurance expert Karl Vahey presents a step-by-step guide to effective root cause analysis. You’ll learn about:

  • The importance of a failure investigation;
  • The key steps in a failure investigation;
  • Investigation tools and examples; and
  • Good investigation practices.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Karl Vahey, Senior Director of QA and Manufacturing in Asia and Europe, Medtronic

Recorded on: June 23, 2016

Description: Quality systems expert Dan O’Leary takes you through the steps of the audit program, describes the interrelationship of the elements, and uses warning letters to illustrate when other companies have had problems. He discusses:

  • The QSR requirements for auditing;
  • How to develop an audit schedule;
  • How to qualify auditors to perform their assigned roles;
  • What should be in an internal audit report; and
  • When to update the audit schedule for a re-audit.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: June 22, 2016

Description: Statistician Steven Walfish outlines the requirements for statistical techniques and sample size and explains how they impact design control processes. He discusses:

  • Common sources of errors;
  • What types of requirements lend themselves to statistics in verification and validation; and
  • Examples of problems in which we apply statistics.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Steven Walfish, President, Statistical Outsourcing Services