Course Description
BSI’s “Process validation for the medical device industry” one day course has been designed to help manufacturers gain awareness of quality requirements regarding validation and the nature of “special processes”. Learn the generally accepted principles of validation, and introduce how-to-do methods of Installation, Operational, and Production Qualification.
We put the tools, formulas and formats in your hands to facilitate quick use in application
Who should attend?
- Quality Engineers
- Test Technicians
- Manufacturing Engineers
- Regulatory Affairs Managers
- Auditors of medical device manufacturing firms (internal and external)
- Product development team
This course will enable you to:
- Appreciate concepts and rationale of process validation
- Recognise the importance of process validation
- Gain awareness of FDA and ISO 13485 expectations and guidance
- Recognise situations where a process requires validation
- Identify process validation terminology
- Demonstrate application of statistics
- Summarize prospective vs. retrospective validation
- Define objectives of equipment and process validations
- Define Installation, Operational and Product qualifications
- Recognise relevant and pertinent factors of PV studies
- Plan for worst case conditions and challenges
- Create validation protocols and a Master validation plan
- Show how to report results
Course Prerequisite
Attendees are expected to have formal education appropriate to the job functions listed above. Some familiarity with FDA/QSR or ISO13485 is helpful. Students must have mathematical skills and bring a personal calculator for use in the exercises. Experience in a medical device manufacturing environment is recommended.
Further information
Fee: 1-day process validation for the medical device industry training course including refreshments, lunch and course notes - £695 + VAT.
Attendance on this course will provide delegates with 8 CPD points.
This course can be delivered as in-company training, customized for specific organizations and their circumstances.
