Basics of Computer System Validation (CSV) in the Pharmaceutical Laboratory. Ten years of GAMP 5: Pitfalls and Best Practices | CPhI North America

 

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Basics of Computer System Validation (CSV) in the Pharmaceutical Laboratory. Ten years of GAMP 5: Pitfalls and Best Practices

Tony Pezzolo (Practice Manager, Compliance and Validation Services / Global CSV SME, PerkinElmer)

Location: E353c

Date: Wednesday, May 1

Time: 2:15pm - 3:00pm

Track: Drug Manufacturing

Vault Recording: TBD

The Pharma approach to the validation of computerized laboratory instruments continues to evolve as regulations grow in complexity and enforcement. The interpretation of the GAMP 5 guidance document is not uniform in the industry, and as such many CSV policies are over-engineered and inefficient. Thus, the time and cost of validating new equipment can grow exorbitant and become a barrier. Best practices need to be deployed that allow for flexibility and streamlining. In other words every pharma company needs a validation paradigm that produces compliance in a less burdensome way. In this presentation we will explore the basic approach to CSV in the pharmaceutical industry and discuss common challenges associated with implementing a GAMP 5 approach as well as best practices.