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. Also to be discussed is how to tackle process validation for medical device combination products.

Issues to be covered include:
•Learn how poor validation procedures and practices can lead to regulatory actions from regulators
•Assurance of product quality derived from a compliant validation program
•Learn how to improve process system knowledge and understanding
•Learn methods for developing process validations and best practices
•Understand the scope of regulations governing process validation and identify gaps
•Develop a plan to rectify existing validation plans, protocols and reports
•Learn how to implement and deploy a master validation plan

Attendees are encouraged to bring examples of Process Validation issues/concerns that they would like to reviewed and discussed during the course.