This one-day intensive course enables greater understanding of the key requirements for manufacturing process validation for medical devices, in line with the European Medical Device Regulations (MDR) and ISO 13485:2016 requirements in Europe. The aim of the course is to enable manufacturers to know what process validation evidence is necessary to demonstrate the manufacturing process is validated.
BSI’s ‘Manufacturing Process Validation for Medical Devices: Introduction to Concepts and Methods’ one-day training course has been designed to give manufacturers an awareness of EU regulatory and quality requirements regarding manufacturing process validation and the nature of ‘special processes’.
Practical activities throughout the day provide the opportunity to apply your knowledge. Learn the generally accepted principles of manufacturing process validation, understand installation, operational and process qualification so you can apply them to your organization.
How will I benefit?
This course will help you to:
- Understand manufacturing process validation
- Improve your understanding of the regulatory and quality standards requirements relating to manufacturing process validation
- Be able to apply your knowledge to your organization, to enable it to produce compliant devices
- Ensure auditable technical documentation meets applicable EU regulatory requirements
This course is ideal for you if you’re in a quality assurance/regulatory/engineering/ manufacturing role involved in medical device design, development and manufacturing.
You should have experience or basic knowledge of manufacturing engineering or quality management systems for the medical device industry. We recommend you have a basic awareness of medical device development and quality assurance.
- Appreciate concepts and rationale of manufacturing process validation
- Recognize the importance of manufacturing process validation
- Gain awareness of relevant ISO 13485:2016 expectations and IMDRF guidance (previously GHTF)
- Recognize situations where a manufacturing process requires validation
- Have the tools to create a Master Validation Plan and validation protocols
- Define objectives of equipment and process validations
- Recognize relevant and pertinent factors of manufacturing process validation studies
- Plan for worst case conditions and challenges
- Identify how process capability studies can be used to validate manufacturing processes
- Complete installation, operational and performance qualification
- Maintain a state of validation
- Recognize when revalidation may be required
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.