The NERC fines for the May 26th period are out and 71.6% of all financial penalties were CIP related. This is a clear indicator that registered entities are having troubles with CIP-004, CIP-007, [...]
Blog Home MONTH: May 2011
Both sides played it pretty nice at yesterday’s press conference unveiling a new study analyzing the FDA’s 510(k) review process, but there’s a tension underneath it all: Industry generally [...]
In Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Regulatory Compliance ManagementPosted
During the last two years of my time with FDA I noticed the amount of Sponsor and CRO inspections triple in number (for CDER, CDRH, & CBER). CRO’s with less than adequately trained clinic [...]
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