Process Validation for the Medical Device Industry

BSI’s “Process Validation for the Medical Device Industry Concepts and Awareness ” one day training course has been designed to give manufacturers an 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 new to process validation
  • Regulatory Affairs Managers 
  • Auditors of medical device manufacturing firms (internal and external)
  • Or anyone requiring a top-up of the EU regulatory requirements

What will I learn?

Upon completion of this training, delegates will be able to:

  • Appreciate concepts and rationale of process validation
  • Recognize the importance of process validation
  • Gain awareness of ISO 13485 expectations and IMDRF guidance (previously GHTF)
  • 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?

By attending this course, you will:

  • Improve your understanding of process validation
  • Be confident your devices meet regulatory, quality and safety standards
  • Be able to apply your knowledge to your business to ensure you produce compliant products
  • Encourage professional development and knowledge sharing

What's included?

  • Training course notes
  • Lunch
  • Refreshments