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Risk-Based Equipment Qualification: Shifting the Paradigm from Leveraging to Integrated

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What is the difference between a leveraged and an integrated approach to Commissioning and Qualification? Are they just different terms for the same approach? Does your current approach to C&Q include non-value-added redundant testing and inhibit speed to market? Do Engineering and Quality often seem at odds throughout the C&Q process? And at the end of the C&Q process, are systems truly fit for purpose when released to their end users? Explore these questions and learn the very real differences between leveraging and integrated C&Q.

 

Based on the revised (2019) ISPE Baseline Guide, Volume 5, this webinar will discuss the changing industry landscape and regulatory expectations for C&Q, and explain how current industry practice incorporates industry and regulatory guidance into an effective, efficient, science and risk-based, integrated approach to C&Q to deliver systems fit for purpose.

 

Benefits:

    • Understand why leveraged and integrated Commissioning and Qualification aren’t just different terms for the same approach
    • Learn the very real differences between leveraging and integrated C&Q, and why it matters
    • Apply the revised (2019) ISPE Baseline Guide, Volume 5 to the changing industry landscape and regulatory expectations for C&Q
    • Understand how current industry practice incorporates ICH Q8, Q9, and Q10, ASTM E2500, and other guidance
    • Understand current industry practice for an effective, efficient, science and risk-based, integrated approach to C&Q to deliver systems fit for purpose.
    • Understand how Engineering and Quality have complimentary roles in the integrated C&Q process

Click Here to Register

 

 

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.