Process Validation - Current Industry Practices and FDA Guidance Document Review

Why Should You Attend:

Process validation is an important subject for the pharmaceutical quality or regulatory professional. Process validation can be difficult and can cause confusion due to different standards, approaches, and process complexities.

In this webinar, the basics of process validation will be explored along with current industry practices. The recent draft FDA guidance document on process validation will be reviewed and case studies will be presented that will allow the attendee to see practical examples of process validation protocols.

Areas Covered in the Webinar:

• 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

Who Will Benefit:

• Quality Control Managers/Directors
• Quality Assurance Managers/Directors
• Validation Personnel
• Regulatory Compliance Professionals
• Product Development Personnel

John R Godshalk
Senior Consultant, Biologics Consulting Group

John R. Godshalk 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. He 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.

Topic Background:

Process validation is required by FDA and most regulatory bodies. Process validation demonstrates consistency of pharmaceutical processes. It 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.

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