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Demystifying Process Validation for Medical Device Manufacturing

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When manufacturing highly regulated products, such as medical devices, it’s not enough to just evaluate product quality through in-process and final inspection activities. An additional process development activity that is required within CGMP regulations from the FDA for medical device manufacturing is process validation, and it applies to both traditional and additive manufacturing processes. In addition, patient-matched medical device manufacturing often involves digital steps of the production process that require validation. Having a validated manufacturing process provides manufacturers with quantifiable data that demonstrates the reliability of their process and establishes confidence that the production outputs meet the quality requirements. While there some distinct steps in both the equipment (IQ, OQ, and PQ) and software (SIQ, SFMEA, SVP, and SVR) validation processes, what each of these steps looks like in detail is highly variable depending on the risk identified for each step of the process, the type of machines you’re using to manufacture parts, the material you’re using, the types of parts you’re producing, how the software functions, etc. However, there are some considerations for each step of validation that apply to all production processes and questions to ask when establishing your process validation activities. In this presentation I will provide an overview of each step of process validation for both equipment and software, and how they apply to additive manufacturing processes, pulling from lessons learned from the Veterans Health Administration VA Ventures team in Seattle, WA during our process validation activities for our recently 510K cleared Oromaxillofacial Advanced Surgical Planning (OMF ASP) System. I will also discuss some important considerations for those new to regulated production processes and help to demystify the regulations for process validation for medical device manufacturing.

Learning Objectives:

  • Upon completion of this presentation, the participant will be able to define what is required for process validation for medical device manufacturing.
  • Upon completion, the participant will be able to describe the different considerations for process validation for both equipment and software and what it means to have a validated manufacturing process.
  • Upon completion, participant will be able to demonstrate understanding of how to write a process validation for their manufacturing process.
  • Arrianna Willis
    Director of Operations - VA Ventures
    Department of Veteran's Affairs Office of Advanced Manufacturing
  • Dmitry Levin
    Clinical Director VA Ventures Veterans
    Health Administration