Writing Validation Master Plans: Best Practices for Authoring a Compliant Document
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 14 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Midsize.
Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.
In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.
This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs. Various regulatory requirements for Validation Master Plans will be discussed as well as effective guidelines for authoring a VMP and a team writing approach to authoring a Validation Master Plans will be discussed. Various types and examples of VMPs will be given and discussed. Participants will learn how to effectively write a VMP most appropriate for their manufacturing organization.
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.
- 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
Course Level - Intermediate to Advanced
Who Should Attend
- Validation Engineers
- Supervisors and Managers
- Quality Assurance personnel
- Engineering Consultants
- Regulatory Personnel
Why Should Attend
Attendees should register to learn the major components of a Validation Master Plans. They will learn how the VMP is different from Validation SOPs. Various regulatory requirements for Validation Master Plans will be discussed as well as effective guidelines for authoring a VMP and a team writing approach to authoring a Validation Master Plans will be discussed.