Reprocessing Reusable Medical Gadgets Cleansing and Labeling Requirements

This webinar will deal with the usage of the FDA, GAMP, 21 CFR Half 11, “Digital Data” / “Electronic Signatures”, and other relevant trade software validation fashions, coupled with the ISO 14971 / ICH Q9 Product Risk Management fashions, to construction, run, and doc acceptable software validations. The FDA and other regulatory agencies have acknowledged that software validation can realistically only be completed effectively if “danger-based mostly”.A How can this are achieved within the “actual world”. This webinar will deal with software that’s:

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