Timur Güvercinci, Merck Healthcare KGaA, Darmstadt and self-employed GMP Trainer and Consultant
To show that a manufacturing process is reproducible is not only state of the art for medicinal products but also for medical devices. The regulatory requirements for process validation regarding medical devices are not as clear as those for medicinal products. There are very general requirements coming from ISO 13485 and from an old Global Harmonisation Task Force (GHTF) guideline dated 2004. Medical devices which are exported to the USA have to fulfil the process validation requirements from 21 CFR 820.75. But how to proceed process validaton in the medical devices industry today according to the state of the art that all requirements are met? Who is responsible for the process validation of medical devices? What documentation is necessary; what statistical indicators are helpful? Are there differences between medical devices and medicinal products? These questions will be discussed during the webinar. Additionally, warning letter findings due to process validation will be presented.
Employees from companies, who are involved in medical devices process validation activities (developers, QM, manufacturing, Regulatory Affairs, etc.) are addressed. Of course, pharmaceutical companies which use medical devices as part of a combination product are addressed too as well as consultants in this field, who want to get information from the view of the medical device industry.
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The following issues will be discussed:
- Overview regulations: ISO 13485, GHTF Guideline Process Validation, 21 CFR 820.75
- What manufacturing types have to be validated (decision tree)?
- Who is responsible for process validation?
- Appropriate risk management techniques
- Validation protocol, record, report
- Statistical indicators
- Similarities and differences regarding medicinal product requirements
- Validation Life Cycle
- Revalidation vs Ongoing/Continued Process Verification
- Examples of FDA Warning Letter findings
Recording from 27.05.2020
Duration of recording: 1,5 h.