ICH E6 GCP Revisions - Webinar CD/Transcript

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ICH E6 GCP Revisions: The New Standard

Every clinical trial operator will feel the impact of the major revision of the ICH E6.  

The revision, known as ICH E6 (R2) GCP, will impose new requirements to use state-of-the-art technology ... force changes in trial design, conduct, oversight, recording and reporting ... and all the while, continue insisting on highest standards of human protection and data integrity.

And that’s just for openers. Also slated for updating: Standards regarding electronic records and essential documents to boost trial quality.

As with all such documents, the requirements are complex and technical. Yet failure to understand and comply risks the wrath of regulators from the U.S. FDA to the Japanese Ministry of Health, Labor, and Welfare (MHLW).

In an information-packed 90-minute presentation, Dr. Susan Leister will help you master:

  • Major changes set forth under ICH E6 (R2) GCP
  • Potential challenges to compliance
  • Impact of compliance changes on your organization
  • How to implement the changes most efficiently and with least disruption
  • Unification of multiple countries — including EU member nations, Japan, Canada and Switzerland — for approval
  • And much more!

Dr. Leister, Director-QA at Technical Resources International, is a recognized authority on achieving and maintaining quality in clinical trials. She is ASQ-certified as a CQA and a CSSBB, and served as a judge in the 2013 ASQ International Team Excellence Awards.

Injury or harm to trial subjects is a sure path to multimillion-dollar lawsuits ... or worse. Isn’t it worth 90 minutes of your time to protect yourself and your organization? Order now.

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  • Clinical Quality Auditors
  • Quality Assurance Personnel

Dr. Susan Leister, Director of Quality Assurance, Technical Resources International
Dr. Leister has over 20 years of industry experience. In addition she has been a part-time faculty member of the University of Phoenix Undergraduate and Graduate School of Business for the last five years. She holds certifications from ASQ as a CQA and a CSSBB. She serves on the ASQ Section 509 Executive Committee and served as a 2012 and 2013 Maryland Performance Excellence Award Examiner and a 2013 ASQ International Team Excellence Award Judge.