Process Validation for Medical Devices Training Course
This one day course has been designed to allow manufacturers gain awareness of quality requirements regarding validation and the nature of “special processes”. Learn the generally accepted principles of validation, and understand Installation, Operational and Process Qualification so you can apply them to your business
Who should attend?
- Quality, product development and manufacturing personnel involved in process validation
- Regulatory affairs managers
- Auditors of medical device manufacturing firms (internal and external)
Attendees are expected to have formal education appropriate to the job functions listed above. Some familiarity with FDA/QSR or ISO 13485 is helpful. Students must have mathematical skills and experience in a medical device manufacturing environment is recommended.
"The course was delivered at the right pace."
What will I learn?
On completion of this training, participants will be able to:
- Appreciate concepts and rationale of process validation
- Recognise the importance of process validation
- Gain awareness of FDA and ISO 13485 expectations and GHTF guidance
- Recognize situations where a process requires validation
- Create a master validation plan and validation protocols
- Define objectives of equipment and process validations
- Recognize relevant and pertinent factors of PV studies
- Plan for worst case conditions and challenges
- Complete Installation, Operational and Performance qualification
- Maintain a state of validation
How will I benefit?
- Reduce development time with better understanding of process validation
- Be confident your devices meet regulatory, quality and safety standards
- Gain access to market earlier with more compliant products
- Increase sales and customer satisfaction
- Encourage professional development and knowledge sharing.
- You will gain 8 CPD points on completing the course
- Training course notes