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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.
This course must be taught at a BioNetwork location.
- 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."
- Technicians in pharmaceutical manufacturing.
- Quality control personnel.
- Engineering/maintenance personnel.
- Quality assurance and regulatory affairs.