Developing a Validation Master Plan

Duration: 75 Minutes
This webinar will provide all medical device companies with a step by step process on how to develop a validation master plan (VMP) for product/equipment transfer, facilities, or to develop a company standard. It will also provide a detailed insight on the best practices for developing and implementing a good plan detailing responsibilities, and deliverables to make validation efficient, and consistent.
Master Validation Plan FDA
Instructor: Marie Dorat
Product ID: 500860

Why Should you Attend:
Attend this webinar to learn in detail how to develop a VMP and what are the best methods to be followed. The Validation Master Plan describes the way an organization approaches validation; who controls the various aspects of the validation activities; and how production, quality, and management will be involved. The VMP also details the validation requirements for each test/ system/ equipment and will guide the organization in achieving its objectives.

Objectives of the Presentation:
This presentation aims at providing the participants a better insight on:
  • What is a VMP and how is it valuable to my company?
  • What topics are covered in the VMP and to what extent?
  • How is the VMP controlled and updated?
  • How is the VMP implemented?
  • Who contributes to the VMP?
Who can Benefit:
  • Quality Assurance
  • Regulatory Affairs
  • Operations
  • Engineers
  • Quality Engineers
$375
Recorded Session for one participant
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Minimum 10 attendees
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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
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies process the necessary documents for international product distribution.

Ms. Dorat has 13 years’ experience in quality assurance and regulatory affairs in the pharmaceutical/Medical Device & IVD industry, including auditing clinical trials, manufacturers, and distributors in the US and internationally. She has held a number of senior QA/RA positions. She has worked for several companies including Pfizer, and Alere She has lectured at conferences and provides on-site training courses on QA and GxP issues.

She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months. She provides training courses both for public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspection- How to Prepare,.
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