cgmpissues.blogspot.com
CGMP Issues: January 2011
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Wednesday, January 26, 2011. 510(k) Costs Can be Misleading. 510(K) COSTS DISCUSSIONS CAN BE MISLEADING. Does any one seriously argue that many bench / functional testing, biocompatibility testing, sterilization, documentation systems, validations (including software), the other basics (including principles of Shewhart, Deming,Juran, et al) required under the cGMP quality management systems and its infrastructure, and yes, some clinical trials, should not be required? John E. Lincoln. J E Lincoln and Ass...