Description:
Every medical device company (OEM) and their CMO’s (suppliers) must meet certain standards for validation of all its processes, manufacturing operations, infrastructure, transfer plans, facilities, and clean rooms. These standards apply for OEM’s and suppliers to OEM’s.
This webinar will instruct the participants on how to develop the validation protocols that will show how to meet the FDA and ISO standards for validations. The planning and execution for your facilities, processes or suppliers will be addressed. This is an important process to establish before being audited to show compliance to the FDA and foreign standards.
This webinar defines the step-by-step procedure for all medical device companies and their suppliers that are in need to plan and execute validation protocols. This webinar can also prepare you for product or equipment transfer; facility or processes upgrade.
Areas Covered in the Session :
Management Responsivities
Effective Planning
Effective Execution
Validation Plan
Validation Approach
Objectives
Protocol Plan
Protocol Approach
Establishing Protocol Process
Installation Qualification
Operational Qualification
Performance Qualification
Quality Assurance ....and more
Who Will Benefit:
OEM Senior Management Teams
CMO Senior Management Teams
Managers and Directors
Managers setting up new facilities and product lines
Supply Chain Managers
Plant and Facility Managers
Plant and Facility Engineers
Facility Designers
Clean Room Designers
End-users responsible for Design Control and Product Development
R&D and Product Development Teams
Project/Program Managers
Process Engineers and Managers
Manufacturing Departments
Validation Departments
Project Managers
Quality Management Departments
Auditors
Suppliers to Medical OEM’s
Consultants
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1595
