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Author: Alpa Patel





August 27, 2014

Equipment Cleaning, Disinfection, and Sterilization Validations – The Tissue Industry’s Compliance Challenge!

Equipment process validations are becoming one of the tissue banking industry’s most pressing regulatory compliance concerns. Until recently, the tissue industry has enjoyed a comparatively less regulated environment than medical device manufacturers and other medtech service providers. But a surge...

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May 15, 2014

Importance of Cleaning and Sterilization Validations, Even When they may Not be Required

Department Scientist-Healthcare Reprocessing I recently attended the 10th Annual FDA and Changing Paradigm for HCT/P Regulation Conference, with my colleague Wendy Wangsgard, Department Scientist, Bioburden. We presented topics of interest that have surfaced the validation realm, in addition to learning...

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