This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product validation. Topics covered include when and how to validate, regulatory requirements and ISO initiatives for the FDA regulated medical device industry, risk- based approach, and how to plan and implement a validation program.
Manufacture/production operators, team leaders and supervisors, Quality Control personnel, Quality Assurance personnel, maintenance/engineering personnel professionals in clinical settings.
- Introduction: factors precipitating FDA’s validation concept and approach
- Define product life cycle concept, what is validated, why is validation important, and when to validate
- Regulatory compliance: role of the FDA, enforcement tools, (Warning Letters, 483's, etc.)
- The influence and impact of modern medical device CGMPs on validation (design control, ISO standards)
- Compare and contrast the 2011 FDA Guidance to Industry “Process Validation: General Principles and Practices and the GHTF guidance for medical devices, Quality Management Systems - Process Validation Guidance, SG3:2004
- Equipment and Systems Qualification: IQ/OQ/PQ, Performance batches, adequate number and batch size
- Structure of a Validation Program: validation documentation, maintaining a validated state, conducting risk assessments
- Understand the motivation and purpose of medical product validation
- Define validation as applicable to the manufacturing process of medical products.
- Learn why, what, when, and how validations are performed
- Understand why validation is important by learning the regulatory basis for drug and medical device validation requirements
- Become familiar with requirements of the 2011 FDA Guidance for Industry, Process Validation: General Principles and Practices, and how it relates to the GHTF guidance, Quality Management Systems - Process Validation Guidance, SG3:2004 with respect to medical devices
- Learn how to get started with designing a compliant validation program from a regulatory and ISO perspective.
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