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Event: Risk-Based Approaches for FDA-regulated Complex Systems

Join RevereIT for this presentation at IVT's Conference in Philadelhia, PA:
  • Discuss the struggles associated with Risk-Based approaches and offer potential solutions
  • Outline ways to use Risk-Based approaches to validate comples systems with and without system modifications
  • Demonstrate how Risk-Based approached can be used for computer system validation
Wednesday, Apr 27, 2016
 
Computer Systems Validation

Computer System Validation (CSV) in regulated operations provides confirmation by examination and provision of objective evidence.

Validation for Vaccine Manufacturers An Introduction

This guidance document has been prepared to aid vaccine manufacturers in the preparation and performance of the validation studies required by GMP.