This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product validation. A brief historical overview of regulatory requirements is followed by current requirements, user needs, process design and control, qualification, process validation, and cleaning validation activities. Hands-on activities are utlized to enhance understanding.
Factors precipitating FDA’s validation concept and approach.
Design, installation, operational, and performance qualification.
Foundational concepts and approaches established by FDA’s 1987 “Guideline on General Principles of Process Validation.”
The “Design Control” approach to medical device validation.
The influence and impact of CGMPs on validation
Validation principles updated by the 2011 FDA Guidance to Industry “Process Validation: General Principles and Practices.”
The regulatory basis for drug and medical device validation requirements.
Gain an understanding of the motivation and purpose of medical product validation.
Differentiate between the qualification and validation practices.
Be orientated to requirements of the 2011 FDA Guidance to Industry "Process Validation: General Principles and Practices" and EudraLex Vol. 4 Annex 15 "Qualification and Validation."