Validation Master Plans discuss validation activities across an entire site or within an organization. It is a summary of validation strategies and its main purpose 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 which assist an organization with validation strategies or provide control over a specific process.
This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs, what are the types and examples of VMPs. Various regulatory requirements for Validation Master Plans , effective guidelines for authoring a VMP and a team writing approach to authoring a Validation Master Plans will be discussed. Participants will learn how to effectively write a VMP most appropriate for their manufacturing organization.
Areas Covered in the Webinar:
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
1. What is a VMP and what is its intended use
2. How is a VMP different that validation SOPs
3. Components of a VMP
4. Regulatory requirements for a VMP
5. Team Writing a VMP
6. Examples of VMPs
7. Effective writing practices for an audit ready document
SpeakersUpon earning a degree in Zoology at North Carolina State University, Joy McElroy 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, Ms. McElroy 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, she moved into equipment qualification and cleaning validation at Mallinckrodt.
With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
In 2013, Ms. McElroy 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.