PDA’s newest technical report Process Validation: A Lifecycle Approach presents timely and real world guidance for the application of a lifecycle approach to process validation. The lifecycle approach has been the focus of recent process validation guidance from major regulatory agencies and represents a significant change in expectations in this area. This new technical report, part of the PCMO(sm) initiative, will review requirements for process validation studies across the three-stage approach defined by FDA and also discuss best practices for integration with supporting Quality Systems.
- Published:
- 02/01/2013
- ISBN(s):
- 9780939459513
- Number of Pages:
- 102
- File Size:
- 1 file , 1.3 MB
- Product Code(s):
- 01060
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