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How – and Why – to Integrate Quality Risk Management (QRM) into Commissioning & Qualification (C&Q)

SeptemberSep 27 2022 02:00pm - 03:00pm

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Join us Tuesday, September 27 at 2:00 PM ET for a complimentary webinar presented by: Chip Bennett, Associate Director, Global C&Q, SME, CQV Program Development, QRM, CAI & Aaron Roth, Associate Director, Global C&Q, CAI.


Register Here


Join Chip & Aaron as they cover:


Why a QRM Approach to C&Q?

  • Understand QRM as a holistic process, and how to apply it to C&Q
  • Understand the regulatory and industry drivers
  • Learn the benefits: scope, schedule, cost, effort, speed to market



Risk Assessment and Risk Control Through Design and Verification

  • Use PPK – CQAs and CPPs – as the basis for QRM
  • Apply QbD using Risk Assessment and Design Review to identify CAs and CDEs
  • Use CAs and CDEs as the basis of the verification strategy



Risk Review Throughout the System Lifecycle

  • Use QRM as the basis for maintaining the state of control/qualified state, periodic review, and requalification
  • Use QRM to drive continuous process improvement, manage change, and support deviation management and CAPA




Register Here

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