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Writing Validation Master Plans: Best Practices for Authoring a Compliant Document

Summary

  • What is a VMP and what is its intended use
  •  How is a VMP different that validation SOPs
  •  Components of a VMP
  •  Regulatory requirements for a VMP
  •  Team Writing a VMP
  •  Examples of VMPs  
  •  Effective writing practices for an audit ready document

Overview

Validation Master Plans discuss validation activities across an entire site or within an organization. The Validation Master Plan is a summary of validation strategies. The purpose of Validation Master Plans is to document the compliance requirements for the site and to ensure that sufficient resources are available for validation projects. 

Validation Master Plans may be written to cover specific departmental validation activities or the validation process for a specific type of system. Validation Master plans are written to assist an organization with validation strategies or to provide control over a specific process.

Who should attend?

  • Validation Engineers
  • Supervisors and Managers
  • Quality Assurance personnel
  • Engineering Consultants
  • Regulatory Personnel 
  • Auditors

Joy L. McElroy

Expert

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification.

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