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

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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


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Chip Bennett

SME, QRM and CQV Program Development, CAI

Mr. Bennett is a PMI® Certified Project Management Professional (PMP) with 19 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and with expertise in risk-based verification, aseptic manufacturing, quality systems, and owner project management. Chip is responsible for developing and implementing Quality Risk Management (QRM) based Commissioning and Qualification programs and projects, with a particular focus on assessing and training clients regarding development, implementation, and transition to risk-based approaches.

Aaron Roth

SME, QRM and CQV Program Development, CAI

Aaron Roth is a seasoned Project Manager and Validation Engineer. He has led several large projects, most recently driving home a $3M risk-based commissioning and qualification project near Boulder, CO. Aaron has successfully applied his engineering and leadership experience and physics education as a consultant across the pharmaceutical industry, including commissioning and qualification of manufacturing equipment, facilities, utilities, instrumentation and control systems, autoclave and steam-in-place processes, process validation, maintenance and reliability planning and management, deviation investigations and root cause analysis, change management, quality system implementation, and GMP training.