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The Validation Master Plan (VMP)

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Your Roadmap to Prepare a VMP that Impresses FDA Investigators

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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

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