Biopharmaceutical Validation and Technical Transfer (single user digital version)

Oct 2018
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PDF Single user
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This document discusses why and how to validate and transfer a process. It offers a helpful example, includes protocol details and discusses non-traditional process validation, life cycle management, change management and much more.

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Format: PDF (1 file 573 KB)

Table of Contents

Table of Contents:

  • A Brief History
  • "Process"
  • "Validation"
  • Process Validation
  • Why Validate?
  • How to Validate
  • Non-Traditional Process Validation
  • Lifecycle Management
  • Change Management
  • Conclusion
  • References

About the Authors

About the Editors

Russel E. Madsen is President of The Williamsburg Group, LLC, providing expert pharmaceutical consulting services including CGMP compliance, quality systems, aseptic processing and sterilization, sterilizing filtration, design review, due diligence, and regulatory liaison. Prior to forming The Williamsburg Group, he had served PDA as Acting President and was Senior VP Science and Technology. Before joining PDA, he was employed by Bristol-Myers Squibb Company as Director, Technical Services, providing technical and general consulting services to Bristol-Myers Squibb operations, worldwide. He is Vice-Chairman of ASTM E55.03 General Pharmaceutical Standards, a member of the USP Microbiology Expert Committee, Chairman of the USP Visual Inspection of Parenterals Expert Panel, a member of Pharmaceutical Technology's Editorial Advisory Board, and an Honorary Member of PDA. He holds a Bachelor of Science degree from St. Lawrence University and a Master of Science degree from Rensselaer Polytechnic Institute.