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 13485:2018 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.
Day 1: Overview
- Basics of process validation
- Overview of the current regulations (ISO 13485:2016, 21CFR820)
- Terminology (IQ, OQ, PQ)
- Validation planning
- Risk-based sampling plans
Day 2: Workshop
- Preparation of a validation plan
- Exemplary IQ- and OQ-protocols
- Integration of risk management according to EN ISO 14971:2012
- Summary and validation reports
Who should attend
People involved in the validation of manufacturing processes, such as:
- QM specialists
- Project Manager
- Executives with responsibility in validation
Certificate of attendance of TÜV SÜD Akademie
This course addresses internationally valid standards and can also be held abroad.
TÜV SÜD Akademie senior expert trainers
- You will be qualified to conduct validations compliant with applicable standards for the manufacturing process of medical devices.
- You will acquire relevant know-how of an efficient process validation, including change management.
- You know the conditions of the implementation of risk-based validation methods.