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Process Validation for Medical Devices
The aim of this course is to learn Process Validation for Medical Devices. The emphasis of this content-rich course is to provide the participants those methods which will enable them to cope with the Validation challenges at the Medical Device industry under the regulatory requirements from the 21CFR 820 FDA and ISO 13485. Special processes, Sample size selection, Validation principles...Continue reading
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Issues to be covered
- Determine the sample size required for the Process Validation execution.
- Regulatory Requirements
- Definitions
- When is process validation required?
- Risk Management and pFMEA
- Process Validation Master Plan – PVMP
- Installation Qualification – IQ
- Test Method Validation – TMV (Variable and Attribute).
- Statistical Aspects of Process Validation for a successful OQ and PQ
- Operational Qualification – OQ
- Performance Qualification – PQ
- Maintaining State of Validation and Guidelines for Re-Validation
- Process Validation Protocols & Reports and Examples
Who should attend
The course is especially useful for individuals involved in Process Validation of medical products and those newly assigned to Process Validation responsibilities. The course offers an excellent opportunity for those who seek to update their knowledge. Professionals may come from industrial, government, academic and/or contract testing facilities, namely:
- Design and Development managers
- Interdisciplinary Engineers and Engineering Managers
- Project managers
- Development teams involved in New Product Design, Development and Introduction
- Quality Assurance and Regulatory staff (Managers and workers).
- Production personnel
- Entrepreneurs who intend to develop a medical product
Benefits to the Participants
Upon completion of this course, you will be able to:
- Understand the regulatory requirements of Process Validation for Medical Devices
- Explain what is, when to perform and how to estimate the extend of Process validation for medical devices.
- Outline a Master Validation Plan for the medical device manufacturing activities.
- Reduce protocol development time for Installation, Operational and Performance Qualifications.
- Evaluate and Analyze Measurement Systems at your Manufacturing Process (TMV).
- Establish process limits for manufacturing critical parameters and validate them.
About The Lecturer
Jose (Yossi) Chvaicer
Senior Project Manager, Validation of Equipment and Utilities Mr. Chvaicer
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