The Best Way to Develop or Improve a Master Validation Plan

Duration: 90 Minutes
Validation Master Plans (VMPs) are written to guide and implement an organization with its validation strategy. The Validation Master Plan is different from a validation procedure (SOP), which describes the WHY for performing validation activities. The VMP describes the WHERE and HOW of a process validation program.
Validation Master Plan
Instructor: Regina Fullin
Product ID: 507598
A VMP outlines the activities involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. This is critical objective evidence to have when being audited by FDA or registrar auditors for ISO13485.

This session will provide a step-by-step procedure applicable to most if not all medical device companies and their suppliers that need a MVP for product/equipment transfers, facilities qualifications, or new production processes.

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
Lack of evidence supporting appropriate process validation is one of the top 5 causes for 483 findings by FDA. The lack of a comprehensive Validation Master Plan (VMP) and well-documented validation procedures are also among the main reasons that the FDA rejects new product submissions. Planning is a critical part of validation and establishing objective evidence of appropriate validation efforts. Establishing a good plan detailing responsibilities, deliverables, and checkpoints is essential to make validation predictable, efficient, and consistent. A VMP describes the way a company approaches validation; that has control over the various aspects of the validation activities; and how production, quality, and management will be involved. The VMP also establishes the validation requirements for each test/system/equipment and will guide the organization in achieving its objectives. Furthermore, a VMP answers the inspector's question: what is your approach towards validation. This webinar provides the creation, implementation, and maintenance of Validation Master Plans.

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 will Benefit
  • Medical device/IVD companies & Manufacturers
  • Quality Assurance
  • Quality Engineers
  • QA Managers
  • OEM Senior management
  • Supplier Senior management
  • Managers and directors
  • Managers setting up new facilities and product lines
  • Plant and facility managers
  • End-users responsible for design control and product development
  • R&D and product development
  • Project managers
  • Facility and clean room designers
  • Process engineers and managers
  • Validation engineers
  • Quality management and engineers
  • Auditors
  • Suppliers to medical OEM's
  • Consultants
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training 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:
Regina Fullin is the Director of Compliance Consulting Services at Compliance Team, Inc. (CTI), where she assists clients in the medical device and pharmaceutical industries to help them achieve ever-increasing compliance to regulations in the Pharma, medical device, and related industries. She began her career more than 20 years ago in a Quality role at Abbott Laboratories, and has worked in Quality roles at other companies, including GE Healthcare. Her particular areas of expertise focus on validation, equipment qualification, complaint handling, technical writing and remediation projects for companies requiring compliance assistance. Within her role at CTI, Regina also uses her writing skills to publish relevant and meaningful articles to help medical manufacturers stay current with regulatory changes, industry trends and improve product quality.

Regina is active in the American Society for Quality (ASQ), an international non-profit organization devoted to serving the needs of quality professionals. Regina is active in the Northeastern Illinois Section (1212) as Past Chair. In addition to her Section involvement, Regina also serves on the ASQ Food, Drug and Cosmetic Division, where she participates in conference/event planning and annual audit. Regina is also a Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and a Certified Manager of Quality-Organizational Excellence (CMQ-OE) with ASQ.
View More