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: 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

Recorded on: June 14, 2016

Description: Regulatory submissions expert Michelle McDonough presents a step-by-step guide for developing clinical evaluation reports required by EU authorities to receive CE-marking. She discusses:

  • How to establish equivalence with existing products;
  • How to conduct a literature search; and
  • Whether countries outside the EU may adopt the same requirements.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Michelle McDonough, Associate Director, Regulatory & Clinical Affairs, Musculoskeletal Clinical & Regulatory Advisers

Recorded on: June 9, 2016

Description: Regulatory experts Andrew Ittleman and Kelly Lightfoot present key trends and policies affecting the regenerative medicine industry in 2016. They discuss:

  • How the FDA is expected to regulate regenerative medicine in 2016 and beyond;
  • How the FDA will deal with ethical issues associated with stem cell research;
  • How the FDA’s oversight of regenerative medicine compares to global regulation; and
  • How associations are influencing the regenerative medicine debate.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Andrew Ittleman, Founder and Partner, Fuerst Ittleman David & Joseph, PL, and Kelly Lightfoot, Senior Associate, Fuerst Ittleman David & Joseph, PL

Recorded on: June 8, 2016

Description: Track and trace expert Bill Fletcher discusses emerging trends in serializing drug products and the systems used to follow prescription drugs as they move through the supply chain. He covers:

  • Current regulations for traceability;
  • Simple methods for deploying serialized child-to-parent aggregation; and
  • Key standards, including Electronic Product Code Information Services (EPCIS).

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Bill Fletcher, Managing Partner, Pharma Logic Solutions, LLC

Recorded on: May 24, 2016

Description: Quality compliance expert Susan Schniepp explains what an SOP needs to be deemed “adequate” by the FDA. She discusses:

  • Systems for tracking how SOPs evolve over time;
  • How to define roles in SOPs for supervisors and operators;
  • Understanding documentation output and the importance of evidence; and
  • When to initiate a formal investigation.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Susan Schniepp, Fellow, Regulatory Compliance Associates, Inc.

Recorded on: May 19, 2016

Description: Quality systems expert Dan O’Leary explains what the FDA really expects for complaint handling through an in-depth review and analysis of agency inspection techniques, QSIT, and Warning Letters. He discusses:

  • Requirements to investigate a complaint;
  • Qualification requirements for people who investigate complaints;
  • Data elements for every complaint investigation; and
  • Effect of UDI on these required records.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: May 18, 2016

Description: Industry experts Aaron Mertens and Jim Polarine discuss the necessary components to be compliant with FDA, EMA and MHRA cleanroom regulations and guidances. Topics include:

  • Effective ways to rotate disinfectants;
  • The most current industry methods for applying disinfectants; and
  • Effective methods for controlling residues.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Aaron Mertens, Technical Service Specialist, and Jim Polarine Jr., Senior Technical Service Manager, STERIS Corp.

Recorded on: May 16, 2016

Description: Former FDA official Kim Trautman gives a comprehensive analysis of this major revision of the international quality standard. She discusses:

  • Consistencies and inconsistencies with other documents in the ISO family;
  • The common elements of the standard that can be implemented by organizations without unnecessary duplication; and
  • Specific areas impacted by the revised standard.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Kimberly Trautman, Executive Vice President, NSF Health Sciences, Medical Device International Services