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Validation Requirements for Computerized Systems- Digital Recording (May 8 2013)

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ISCT Webinar: Validation Requirements for Computerized Systems
Presented by the ISCT Lab Practices Committee
Date: May 8th, 2013
Chair:  Karen Snow, BS, (ASCP)BB, CQA(ASQ), Quality Manager, Massachusetts General Hospital, Bone Marrow Transplant Program

Speaker: Andrew Havens, ECL2 Quality Solutions

About the Webinar:
Computerized Systems are becoming more prominent in, and in some cases, an integral part of cellular therapy processes. Quality management Systems, Lab Information Management Systems and Inventory Software are just a few examples. According to 21 CFR 1271.160b.6.d regarding computers, the agency states we must validate the performance of computer software for the intended use when we rely on the system to comply with core cGTP requirements, whether custom designed or commercially available  However, the term "Validation" is open to a wide range of interpretation. How does a facility go about properly validating something as complex as a computerized system?

This webinar will outline a robust and proven method for complete computerized system validation. It will include rationale for validation, discussion on risk assessment, document examples including content, to include requirement and test case examples. This webinar will give attendees a solid foundation from which to design a robust validation process which will withstand FDA inspection scrutiny.
Learning Objectives:

  • Describe why validation of a computer system is essential
  • Examine what is different from a standard process or equipment validation
  • Illustrate components of a robust and inspection resilient Computerized System Validation Plan
  • Evaluate what you need, including specific documents and what they contain
  • Propose risk mitigation strategies to include and test against

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