May 2018
Intermediate to advanced
236 pages
5h 39m
English

William I. White started Quality System Strategies LLC in 2006, when he retired after 30 years at Bayer HealthCare LLC. At Bayer, after 20 years in R&D, he worked with colleagues in the mid-1990s to establish the design control system for the diagnostics division. He then became manager, Quality Systems Strategy, and in that role served as principal architect for the worldwide quality system of the division.
Since retiring from Bayer, he has advised medical device companies ranging in size from a few persons to several thousand persons on how best to fulfill requirements of 21 CFR 820 and ISO 13485 while creating quality systems ...
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