Webinar on Developing IQ, OQ, PQ Protocols as Part of a Validation Plan

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