Process validation in the medical device industry – Module 2: Workshop
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- Process validation in the medical device industry – Module 2: Workshop
The workshop expands on Module 1 and can only be booked together with Module 1. Module 2 includes exercises and examples for qualification of equipment and production facilities, as well as for validation of unverifiable manufacturing steps. In particular, this includes the non-detachable bonding technologies, cleaning procedures, sterile packaging and sterilisation, as well as the software in production facilities if necessary.
The team taking part should apply their newly gained knowledge under supervision and create a detailed plan for an example equipment qualification and/or process validation procedure. The workshop can be based on a real process within the company that requires qualification or validation.
- Definition of the process, identification of process steps as a basis for validation
- Creating the risk assessment concept, specifying assessment criteria and risk estimation
- Performing part of the risk assessment as a team under supervision and guidance; determining which process steps must be validated
- Planning the qualification/validation process under supervision, creating the concepts for the required plans, specifying acceptance criteria
- Creating a raw data acquisition concept
- Planning the assessment and reporting processes
Target group / seminar duration and certificate
The seminar can only be booked together with Module 1 and is suitable for employees who plan, implement and document the qualification of equipment and validation of manufacturing processes. It is also suitable for employees involved in approving the processes, such as staff who are responsible for regulatory aims, auditors, and employees in quality management or quality assurance.
The content is presented over the course of a one-day seminar. The participants receive a certificate of attendance and, on request, materials for participants in physical or digital form.Seminar inquiry