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A Step-by-Step Approach to Process Validation (PHDV79)
Using a sample product to demonstrate the “nuts and bolts” of process validation, this program outlines the important tasks performed during each phase of the validation life cycle. You'll learn what type of information should (and should not) be included in validation documents and why processes must be monitored once they are validated.
Tasks commonly executed during the IQ, OQ and PQ
Detection and response to variation in processes
2 Applicable sections of 21 CFR Parts 211 and 820.
FDA Guideline on General Principles of Process Validation.
FDA Guide to Inspection “Solid Oral Dosage Forms Pre/Post Approval Issues.”
FDA Guide to Inspection “Validation of Cleaning Processes.”
Process Validation Guidance for Medical Device Manufacturers, Global Harmonization Task Force, SG3. Document GHTF.SG3.N99-10, June 1999.
Note: A basic understanding of the principles of process validation is recommended. Key Concepts of Process Validation serves as a prerequisite for this lesson.
All students who successfully complete this online GMP training course will receive a certificate of completion.