ICH Q9 Quality Risk Management

Right now the pharma industry needs quality risk management (QRM) advice that is focused, tried and proven useful, to save time, effort, and ultimately cost. Overcome reticence in applying QRM. Learn how to document it effectively within your company culture and embed it into everyone's understanding.At the conclusion of this course, participants will be able to:

  • Understand tthe basic principles of Quality Risk Management (QRM) as described by the contents of ICH Q9
  • Be aware of the portential applications for QRM at their own sites
  • Be better prepared to understand the detailed information regarding QRM
David D. Dolgin
Validation/QA Consultant
BioTechnique
Instructor

David D. Dolgin is a Validation/QA professional with 35+ years of pharmaceutical experience, the previous 24 as part of Abbott Labs and AbbVie Global Pharmaceutical Operations. Prior to his retirement from AbbVie Inc. in Feb. 2015, Dave was Quality Program Manager for the Operations Quality unit of AbbVie. Since retiring from AbbVie, Dave has continued his industry involvement as a Senior Validation Consultant for BioTechnique LLC, and a contributor to ISPE guidance document teams.

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