Medical Devices 2011 - Medical Device Process Validation - FDA Inspectors are Checking

Why Should You Attend:
In your manufacturing processes, how can you be sure the output is right if you don’t check every piece? Many manufacturers face this problem, but don’t always have a good solution. The FDA expects you to answer it using process validation. Using the Quality System Inspection Technique (QSIT) the Inspector will ask for process validation procedures and the results for your product. Product, as defined by QSR includes components, in-process devices, and finished devices.

Do you know which processes in your firm require process validation? Can you provide objective evidence that you evaluated each process and documented the decision?

With the FDA looking closely, can you show how the product requirements moved from design through Design Transfer to Production? Can you show that you validated and monitor the production processes? The lack of procedures and data can lead straight to 483s, warning letters, and even product seizures.

Attend this full day webinar with quality and compliance expert Dan O’Leary and you can learn the established methods to validate and control your processes.

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