Process Validation for Medical Devices

Due to nature and complexity of medical devices, final inspection as the only production control will not be enough. Process validation offers an adequate toolbox to achieve safe design of manufacturing processes and to deliver evidence of their capability to manufacture medical devices within predetermined specifications. This seminar will deliver a clear understanding of the terminology used, solid regulatory knowledge and many practical examples for the planning, executing, reporting and maintenance of process validations in an efficient and sustainable manner. The contents of the seminar are based on international standards and regulations for medical devices including GHTF, ISO 13485:2016 and 21 CFR 820 (FDA). In addition, key elements of equipment qualification, statistical sampling plans, change control and the monitoring of validated processes are included using risk-based approaches.