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


Tuesday,  September 27 | 2:00PM ET

Presented by: Chip Bennett, Associate Director, Global C&Q, SME, CQV Program Development, QRM, CAI & Aaron Roth, Associate Director, Global C&Q, CAI

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

SPEAKERS


Chip Bennett

Associate Director,
Global C&Q, SME, CQV Program
Development, QRM, CAI


Chip Bennett, Assistant Director, Global C&Q, CAI is a QRM SME and lead CQV Program Development SME. A Project Manager and Senior Validation Engineer, Chip is a PMI® Certified Project Management Professional (PMP) with 20 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and with expertise in risk-based verification, aseptic manufacturing, cleaning validation, 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

Associate Director, Global C&Q, CAI


Aaron Roth is a seasoned consultant, project manager, and subject matter expert in the fields of risk-based Commissioning and Qualification and Quality Risk Management (QRM). Aaron has applied his engineering and leadership experience across the pharmaceutical industry, including commissioning and qualification, process validation, maintenance and reliability planning and management, deviation investigations and root cause analysis, change management, quality system implementation, and GMP training. He has led the implementation of QRM principles on several large projects, as well as at the program level, and has delivered a variety of training to both clients and industry on this topic.

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