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Implementing ASTM Standard for Verification (C&Q)
Implementing ASTM Standard for Verification (C&Q)
Implementing ASTM Standard for Verification (C&Q)

Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E 2500-07 ensures GMP facilities and equipment are: "fit for use," perform satisfactorily, and may be used in the manufacturing, processing, packaging, and holding of a drug. This webinar reviews this approach and identifies critical aspects of manufacturing systems that will provide the focus for qualification/verification activities and allow for Good Engineering/Commissioning Practices to apply throughout the project lifecycle. At the conclusion of this session, participants will be able to:

  • Relate the ASTM Standard to GMP regulations and guidance documents
  • Explain the regulatory foundation for the risk-based approach
  • Understand the 2001 ISPE Baseline® Guide: Commissioning and Qualification Volume 5 and how it links to new concepts in the upcoming Baseline Guide: Science and Risk-Based approach for the Delivery of Facilities, Systems, and Equipment
  • Differentiate qualification versus verification
  • Differentiate between the new risk assessment approach versus the old one
  • Understand how the new draft USFDA Process Validation Draft links to ASTM E 2500
  • Understand the details on verification process flow
  • Implement verification through the C&Q process (FAT, SAT, IV, FV, PT)
  • Understand ways GEP can be used as a foundation for verification

  • Approximate Course Duration: 90 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
    Discounted member price: 0.00
    Your price: 110.00
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    Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E 2500-07 ensures GMP facilities and equipment are: "fit for use," perform satisfactorily, and may be used in the manufacturing, processing, packaging, and holding of a drug. This webinar reviews this approach and identifies critical aspects of manufacturing systems that will provide the focus for qualification/verification activities and allow for Good Engineering/Commissioning Practices to apply throughout the project lifecycle

    Member Price: $ 0.00 / € 0.00
    Non Member Price: $ 110.00 / € 110.00
    Item #: WEBASTMCQEU