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Lean C&Q: Strategy, Schedule and Success
Lean C&Q: Strategy, Schedule and Success
Lean C&Q: Strategy, Schedule and Success
Taking the foundation principles of lean thinking, coupled with years of streamlined C&Q execution experience, this webinar presents a practical approach to lean C&Q. This approach is broadly based on ASTM E 2500-07 principles coupled with key perspectives from ICH Q8R, Q9 and Q10. It focuses on what is important up front at project kick-off for a better chance of getting it right the first time. At the conclusion of this session, participants will be able to:
  • Understand the value and the process development of a of lean C&Q process
  • Use of lean C&Q tools
  • Apply the principles of lean C&Q to your work across platforms, including not only your perspective, but also those of regulatory, operational, engineering, vendors, contractors and maintenance professionals, leading to a fully integrated &Q approach that will give a more quality-focused effort, on time and on budget

  • Speaker Biography
    Alice Redmond, PhD. is a Vice President with Commissioning Agents, Inc. She formerly worked as CQ Technical Director with PM Group, she has over 20-years’ worth of experience in R&D, Pharmaceutical (API, Formulation Fill, Solid dosage) and Biotechnology the industry. Alice graduated with a BSc in Biotechnology in 1987, PhD in Biotechnology in 1991 and a MBs in 2001. Current responsibilities include oversight of regulatory compliance, GEP, quality, commissioning, qualification and validation strategies on a corporate level for PM Group. Alice has led number C&Q projects for numerous multinational clients on a global basis and is currently actively working on Consultancy assignments including ASTM E2500-07 implementation, Technology transfer, process validation, lean C&Q and practical risk assessment strategies. Alice is an active member of the ISPE and PDA, and was a recent award winner of 2009 ISPE article of the year for ´An Industry perspective on the Draft Process Validation Guide.
    Discounted member price: 49.00
    Your price: 149.00
    You could save 67.1%
    This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

    ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

    Approximate Course Duration: 60 minutes (this is a self-paced course)

    *NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

    ISPE CEUs: .10 ISPE CEUs will be awarded upon successful completion of grading requirements

    Member Price: $ 49.00 / € 45.00
    Non Member Price: $ 149.00 / € 136.00

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