Process Validation for Medical Devices Understanding What the FDA Is Looking For
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While CDRH had planned to adopt the GHTF guidance document, those plans have stalled.
Without guidance, device manufacturers may not get a clear-cut direction on which process to validate and when they need validation.
Join Dan O’Leary, president of Ombu Enterprises, for a 90 minute deep-dive webinar that will provide answers to your questions about setting up an effective system.
Your production processes are running smoothly and everything looks fine. Are you ready for an FDA investigator to check your decisions?
The investigator will likely ask two important questions. And you’d better have a good — and thoroughly and properly documented — answer at the ready. Can you confidently answer these questions concerning all your validation processes?
- Do you know when a process requires validation?
- Do your quality plans document your decisions?
Even though CDRH hasn’t adopted the GHTF guidance it is a valuable source of information and assistance. This webinar will help you answer these important questions:
- The investigator will follow the QSIT — do you know the ins and outs of it and what it really says?
- The investigator will have been trained on the GHTF guidance document. Do you know what expectations come from this training?
- Of course, there are the regulations in 820.75. Do you understand the three sets of requirements for process validation?
- Have you reviewed the current warning letters related to device process validation to understand the trends and what FDA is focusing on?
In just 90-minutes, get the total picture of process validation you need to ensure a successful inspection and avoid compliance problems.