Master Validation Plan - A Complete Package

Duration: 90 Minutes
This course will provide guidance on best practices for developing and implementing a good plan detailing responsibilities and deliverables to make validation efficient and consistent. It will provide a step-by-step guidance for medical device companies that need to develop a validation master plan (VMP) for product/equipment transfer, facilities, processes or to develop a company standard.
Master Validation Plan
Instructor: Marie Dorat
Product ID: 501173
Objectives of the Presentation
  • 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?
Why Should you Attend
The Validation Master Plan webinar describes the way an organization may approach validation; help identify 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.

Areas Covered
  • Overview of Validation Master Plan
    • What is a VMP?
    • Which regulations apply?
  • What topics are covered in the VMP?
    • Master Validation Plan content
    • Purpose
    • Scope
    • Project approach
    • Key activities
    • Project organization
    • Communication plan
    • Quality assurance
  • Who are the VMP Key contributors? Defining their roles
    • Quality Assurance
    • Regulatory Affairs
    • Operations
    • Engineering
  • Implementation of the VMP
    • Training requirements
  • Controlling and updating the VMP
Who can Benefit
  • Medical device/IVD companies & Manufacturers
  • Quality Assurance
  • Quality Engineers
  • QA Managers
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
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  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • 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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