Quality Systems Educational Forum: Production and Process Controls

The FDA Medical Device Industry Coalition (FMDIC) held a 1-day educational forum on the Production and Process Control (P&PC) subsystem of the FDA Quality System Regulation (QSR) at the Crowne Plaza Dallas Market Center Hotel on April 23, 2004. Specific subjects focused on P&PC, FDA 483 trends and applicable regulations, software validation, process validation, product acceptance (including statistical techniques and purchasing controls) and device history records with plenty of case studies. Texas A&M University offered Continuing Education Units (CEU) to those in attendance. Registration included materials, continental breakfast, lunch and refreshments.

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Last modified: 02/26/10