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.
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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