BioNetwork Course: Fundamentals of Validation

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 utilized to enhance understanding.

Topics Include

• 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.

Learning Objectives

• 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."

Audience

• Technicians in pharmaceutical manufacturing.
• Quality control personnel.
• Engineering/maintenance personnel.
• Quality assurance and regulatory affairs.