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Webinar: QMS and Inspection Readiness

Reviewing The Components Of Quality Management Systems And How They Affect Inspection Readiness Especially In The Context Of The New ICH E6 R2 Requirements

Thursday, July 6, 2017  |  10:00 am EDT  |  1 hour



The concept of risk management has been discussed in the context of clinical research for several years. With the adoption of ICH E6 R2, Risk-based Quality Management for clinical trials has become an obligation. Risk assessment, risk-proportionate oversight, and quality management approaches must be documented and justified.  This documentation is to be controlled and maintained.  Auditors and inspectors – who base their evaluation mainly on ICH-GCP guidelines – will take them into account and determine compliance of the risk-proportionate procedures and processes documented.  Risk-proportionate approaches extend even to ascertaining the content of the TMF.

  • Review the implications of ICH E6 R2
  • Share ideas and processes for its implementation
  • Illustrate its relevance to TMF content and inspection readiness


Steve Whittaker

Executive DirectorAvoca Quality Consortium

Senior ConsultantThe Avoca Group


Click here for full event details.