Process Validation for Medical Devices

By the end of this course, participants will learn how an effective process validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety. 

Issues to be covered include:

Assurance of product quality derived from a compliant validation program
Learn best practices of protocol writing
Understand the scope of current validation programs, and identify gaps
Develop Remediation Plans
Learn how to implement and deploy a Master Validation Plan
Learn how poor validation procedures and practices can lead to regulatory actions from regulators