GAMP® Validation Protocols for Efficient Documentation

Instructor: David Nettleton
Product ID: 701044
  • Duration: 60 Min
This session describes how to use the GAMP® standard to determine what has to be validated and explains how to create documentation that will meet regulatory requirements worldwide.
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Why Should You Attend :
This session describes how to use the GAMP® standard to determine what has to be validated. It describes how to determine the right amount of validation documentation for a system. It also covers proven techniques for creating documents that meet regulatory requirements.

Areas Covered in the seminar:

  • Understand GAMP® and FDA requirements.
  • Understand what does and does not need to be validated.
  • Learn which documents to use for different validation requirements.
  • How to create documents efficiently.

Who will benefit:

  • IT
  • QA
  • Managers

NOTE: GAMP® is a registered trademark of ISPE. To learn more about GAMP®, visit www.ispe.org

Instructor Profile:
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is “Risk Based Software Validation - Ten easy Steps” that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 169 mission critical software validation projects.

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Seminars by Ex-FDA Officials

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