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Process Validation - current industry practices and FDA Guidance Document Review  

Date & Time: Course "Process Validation - current industry practices and FDA

 

Guidance Document Review" has been pre-approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion.

  

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Instructor Profile: Tuesday, October 2, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: John R. Godshalk

Location: Online

Price : $245.00

John R. Godshalk Senior Consultant, Biologics Consulting Group, LLC

(for one participant)

Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that explores either natural variation or introduced variation in a process and shows that the process can consistently produce a quality product. Writing and executing good process validation can be a daunting task given the complexities of today's biotech and pharmaceutical processes. Guidance's are helpful in writing process validation protocols and deciding what can be, or should be, varied in the process. The notions of critical process control parameters and control limits are introduced and explored as tools for performing process validation.

Areas Covered in the Session: l l l l l l

Recent Guidance Documents Industry Practices Examples of Process Validation Protocols What should be included in Process Validation Protocols The Importance of Good Process Validation Common mistakes in Process Validation

 

John currently works for the Biologics Consulting Group as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy. He has audited/inspected hundreds of pharma and biotech companies and reviewed processes and PV at these plants. John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements. John received his B.S. in chemical engineering from N.C. State University and his M.S.E. in biochemical engineering from Johns Hopkins University. ...more

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Process Validation - current industry practices and FDA Guidance Document Review