OR WAIT null SECS
James P. Stumpff, RPh, is principal consultant with Parexel International, jim.stumpff@parexel.com.
March 15, 2022
This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.
July 01, 2020
Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.