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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

 

Click Here to View the Webinar

 

 

Speakers

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.