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