This course 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.
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. 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.
Areas to be Covered:
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?
Overview of Validation Master Plan
What is a VMP?
Which regulations apply?
What topics are covered in the VMP?
Master Validation Plan content
Who are the VMP Key contributors? Defining their roles
Implementation of the VMP
Controlling and updating the VMP
Who will Benefit:
Marie Dorat, CQA,CAA is a QA/RA compliance, and Training Consultant in the Pharmaceutical/Medical Device & IVD Industry. She is the CEO of IPRF, LLC which specializes in helping established and start-up companies develop and/or update their quality management systems. IPRF also assists companies process the necessary documents for international product distribution.
Ms. Dorat has 14 years experience in quality assurance and regulatory affairs in the Pharmaceutical/Medical Device & IVD industry, including GxP Auditing Quality Management System development, Training, validation and Supplier Management Program development in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies. She has lectured at conferences and on training courses on QA and GXP topics.
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 conducts training courses for both 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 inspections.