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.

Course Aim

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.

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

What will I learn?

On completion of this training, you’ll be able to:

• 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

Who should attend?

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.

Course Duration

1 day

How will I learn?

Our unique accelerated approach fast-tracks learning, improves knowledge retention and ensures you acquire the skills to apply your knowledge straight away. This course involves practical activities, group discussions and classroom learning to help you develop a deeper understanding of the material and have a greater impact on job performance.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

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.

Further Information

Detailed course notes are provided.

Related Training

Requirements of the Medical Device Regulation (MDR) Training Course, Implementation of the Medical Device Regulation (MDR) for CE Marking Training Course, Implementation of the In Vitro Diagnostic Device Regulation (IVDR) for CE Marking Training Course, and Medical Device Directive (MDD) to Medical Device Regulation (MDR) Transition Training Course.

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

• Students need to connect to the class from any internet accessible location.
• Webcam and Microphone are REQUIRED.
• ALL course times shown are US EASTERN TIME.

If your class is In-person :

• You are encouraged to bring a laptop with you to class.
• Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.