Writing Validation Master Plans; Best Practices for Writing a Compliant Document

Attendees should register to learn the major components of a Validation Master Plans, They will learn how the VMP is different from Validation SOPs, Also It will discuss how the VMP is different from Validation SOPs, And Participants will learn how to effectively write a VMP most appropriate for their manufacturing organization.

Joy McElroy
Instructor:
Joy McElroy
Date:
Friday, April 5, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502460

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Overview:

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.

Why should you 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.

Areas Covered in the Session:

  • 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

Who Will Benefit:
  • Validation Engineers
  • Supervisors and Managers
  • Quality Assurance Personnel
  • Engineering Consultants
  • Regulatory Personnel
  • Auditors


Speaker Profile
Joy McElroy Upon earning a degree in Zoology at North Carolina State University, She 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 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. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.

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.

Upon earning a degree in Zoology at North Carolina State University, She 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 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. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.

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.




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