Production Process Validation: A Short Hitchhiker’s Guide
Yuval Shapiro is the founder of QWV – Quality with Value, QA/RA Services. An expert for products and companies primarily related to medical devices that meet the real needs of their clientele. Substantial experience gained in various multi-discipline technology industries (Military, Telecom & Medical Devices), and give a high-value contribution to quality and reliability projects related to the medical device and telecom industries. More than 20 years of experience in QA; including MD&D RA & QA;QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH&S Systems; QA/RA representative in R&D Projects; Risk Analysis as per ISO14791& ISO31000; EMC & Safety Certifications.
Process Validation in the Medical Device industry is a a vitally important component of your Quality Management System. While reasonably straightforward in principle, a poor implementation may lead to uncertainty which in the worst case can result in costly field actions. So how do you determine which process to validate and what are the keys to good process validation?
the session, Mr. Yuval Shapiro shall present the overall process required for the planning and executing of Production Process Validation. He shall elaborate when a Production Process Validation is required and provide examples for processes that require validation. He will discuss the required sampling for the different steps of the validation. Production Process Validation is both a quality and regulatory requirement
that is aimed to ensure that products comply with the requirements,
when their compliance cannot be verified throughout the production
process and/or installation are validated.
- Definitions of Production Process Validation
- The validation process steps (IQ/OQ/PQ)
- Sampling plans
- Protocols and reports
Course Level - Basic - Intermediate
Who Should Attend
- Quality Engineers
- Quality Managers
- Production Engineers
- Production Managers
Why Should You Attend
Many discuss the need for validation: When it is required? How it should be done? Who can perform the validation? What is the desired process for validation? In this presentation the overall process of Production Process Validation shall be discussed while providing examples when validation is required, who is responsible for validations, when should we re-validate, how many items should be considered as a representative, and more. Referrals to guidelines and standards will be provided.