Part 11 Compliance Policy Guide

WITHDRAWN BY FDA Feb 2003 as not representative of their current thinking

FDA’s Office of Regulatory Affairs updated their compliance policy guide to include guidance for enforcement of 21 CFR Part 11 Electronic Records;Electronic Signatures. This together with the transfer of Paul Motise (the lead author and advocate of this regulation) from CDER to ORA and news of a training program for a large group of inspectors indicate enforcement activity for this regulation is ramping up.

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.