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Fundamentals of Validation
This course may be taught at any location.
Level: Intermediate
Lecture Hours: 8.00
Lab Hours: 0.00
Total Contact Hours: 8.00
Description
This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product validation.
This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical device product process validation.
A historical overview of the regulatory requirements is followed up by current requirements leading to user needs, process design/control, as well as qualification, process validation, and cleaning validation activities.
Content studies includes design qualification, installation qualification, operational qualification, and performance qualification.
Additionally, hands on activities are carried out throughout the course to solidify content studied.
Topics Include
The course is 8 hours, conducted in one 8-hour session and covers:
- Introduction: factors precipitating FDA’s validation concept and approach
- Foundational concepts and approaches established by FDA’s 1987 “Guideline on General Principles of Process Validation”
- Medical device validation: the “Design Control” approach
- Modern cGMPs' influence and impact on validation
- Validation principles updated by the 2011 FDA Guidance to Industry “Process Validation: General Principles and Practices”
Compare and contrast the 011 FDA Guidance to Industry “Process Validation: General Principles and Practices” with the 2015 EudraLex Vol. 4 Annex 15 “Qualification and Validation” Guideline
- The regulatory basis for drug and medical device validation requirements
Learning Objectives
- Know the motivation and purpose of medical product validation.
- Understand the difference between qualification and validation practices.
- Be orientated to and familiar with 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, and Engineering/Maintenance as well as personnel in Quality Assurance and Regulatory Affairs study the foundational principles and regulatory requirements of current drug, biologic and medical device product process validation.
