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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
Discounted member price: 49.00
149.00
You could save 67.1%

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.

 

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

Member Price: $ 49.00 / € 40.00
Non Member Price: $ 149.00 / € 110.00
Item #: WEBASTMCQUS