2016 - Webinar on How to Develop a Master Validation Plan
Date2016-01-25
Deadline2016-01-25
VenueOnline, Canada
KeywordsMaster Validation Plan; Medical device validation; Webinar
Topics/Call fo Papers
Description :
Every medical device company (OEM) must meet certain standards for validation of its transfer plans, facilities, clean rooms and processes. These standards apply for OEM’s and suppliers to OEM’s. Many medical companies have never had a Master Validation Plan for their facilities, processes or suppliers. This is an important standard to have when being audited to show on big picture compliance to FDA and foreign standards.
This webinar on “How to Develop a Master Validation Plan” (also known as Validation Master Plan) will provide a step-by-step procedure for all medical device companies and their suppliers that are in need of developing a plan for product/equipment transfer, facilities, processes or to develop a company standard.
Areas Covered in the Session :
Master Validation Plan content
Revision history
Background
Objective
Purpose
Scope
Project approach
Key activities
Project organization
Communication plan
Quality Assurance
Facility approach
Validation approach
Schedule
Budget ...and more
Who Will Benefit:
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
Every medical device company (OEM) must meet certain standards for validation of its transfer plans, facilities, clean rooms and processes. These standards apply for OEM’s and suppliers to OEM’s. Many medical companies have never had a Master Validation Plan for their facilities, processes or suppliers. This is an important standard to have when being audited to show on big picture compliance to FDA and foreign standards.
This webinar on “How to Develop a Master Validation Plan” (also known as Validation Master Plan) will provide a step-by-step procedure for all medical device companies and their suppliers that are in need of developing a plan for product/equipment transfer, facilities, processes or to develop a company standard.
Areas Covered in the Session :
Master Validation Plan content
Revision history
Background
Objective
Purpose
Scope
Project approach
Key activities
Project organization
Communication plan
Quality Assurance
Facility approach
Validation approach
Schedule
Budget ...and more
Who Will Benefit:
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
Other CFPs
Last modified: 2015-12-03 21:42:29