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The Validation Master Plan (VMP)

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The Validation Master Plan (VMP)

Your Roadmap to Prepare a VMP that Impresses FDA Investigators

  • Instructor: Gamal Amer

  • Duration: 60 Min

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A VMP describes aspects for qualifying your facility, including written procedures for equipment and systems validation and maintaining the qualified state. FDA’s Guidance suggests that Process Validation is a three-stage approach and Stage 2 requires proper qualification of the process and facility prior to conducting a Process Performance Qualification (PPQ). This webinar defines what you now need to do to develop the right VMP that complies with FDA’s current expectations.

 

Top 10 Reasons to Attend:

  1. Review FDA’s Process Validation Guidance and the lifecycle approach
  2. Dive into Stage 2 and the concept of Process Performance Qualification (PPQ)
  3. Know the key elements of VMPs
  4. Understand which process and facility components need to be qualified
  5. Prepare a plan that ensures approval
  6. Gain insight on how to conduct the qualification
  7. Assemble the right team and assign responsibilities
  8. Discuss a change control strategy
  9. Understand the concept of maintaining the validated state – Stage 3
  10. Receive a VMP example

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Laboratory

Gamal Amer

Ph.D., Principal, Premier Compliance Services, Inc.

Dr. Amer, a chemical engineer by training, has 40 years-experience in the pharmaceutical and related industries. He has held senior management positions with leading pharmaceutical, consumer products, and engineering consulting companies. His experience includes comprehensive process design in bulk pharmaceutical chemicals manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing, and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. Dr. Amer is a recognized expert in GMP compliance and validation. He has lectured extensively in the US, Europe, Asia, and the Middle East and taught many courses on subjects such as controlled release technology, GMP trends, Validation and Change Control, and implication of GMP compliance on process and facility design in the biotechnology industry.

Education:

Ph.D. BioChemical Engineering, Virginia Polytechnic Institute & State University
M.S. Chemical Engineering, Virginia Polytechnic Institute & State University
B.Sc. Chemical Engineering, Cairo University

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