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

Duration: 75 Minutes
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.
Writing Validation Master Plans
Instructor: Joy L McElroy
Product ID: 505727
Objectives of the Presentation
  • 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
Why Should you Attend
A VMP is a document that details the way a company will operate, who has control over the various aspects of the validation activities, and how production, quality control, and personnel management will be directed. The VMP allows companies to agree upon and document an overall validation strategy, which can be provided to regulators to serve as clear justification for the validation effort. The VMP allows manufacturers to show they are in control of their quality system and focused on quality. Attendees should register to learn the major components of a Validation Master Plans. They will learn how the VMP is different from Validation SOPs.

Who will Benefit
  • Validation Engineers
  • Supervisors and Managers
  • Quality Assurance Personnel
  • Engineering Consultants
  • Regulatory Personnel
  • Auditors
  • Quality Control Departments
  • Research and Development Departments
Topic Background
An effectively written VMP is critical to an organization's success as a quality manufacturer as well as to regulatory compliance. Poorly written VMPs are the source of numerous 483s and warning letters issued by the FDA. VMPs must be written in a concise, to the point, and comprehensible manner. Write as if the reader has no prior knowledge - this will result in simple, specific terms. Always write in active voice using present-tense verbs, and never give the reader a choice by using words like "may" or "should." Be direct and decisive. A well-written and organized VMP will give clear direction and instruction for avoiding deviations and ensure the manufacture of quality products.
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the 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 19 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, Technical Writing, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest.

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing.

In 2013 Joy started, Maynard Consulting Company, which provided engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States.

In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off site training to pharmaceutical and biotech companies throughout the United States, Canada, and the world.

Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.
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