Content by ISPE
21 CFR Part 11 Course at ISPE 2010 Philadelphia Training EventCourse features latest information on the status of FDA’s current reexamination
Tue, 11/02/2010 - 10:49
(ISPE, Tampa, FL) -- ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, will offer seven training courses, including a session focused on complying with 21 CFR Part 11, at its 2010 ISPE… Product Quality Life-Cycle Implementation GuideFirst in a how-to series to help develop and implement pragmatic approaches to product realization
Mon, 10/25/2010 - 13:04
(ISPE: Tampa, FL) -- ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, has released a new good practice guide (GPG) titled Product Quality Lifecycle Implementation (PQLI) Guide: Overview of… Event: FDA-ISPE Collaboration: Pharmaceutical Quality SystemsEvent to focus on pharmaceutical quality systems.
Fri, 05/07/2010 - 10:41
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global nonprofit association of 24,000 pharmaceutical science and manufacturing professionals, and the U.S. Food and Drug Administration (FDA) are co-sponsoring… ISPE Releases Guide on Electronic Records and Signatures Good Practices
Tue, 04/26/2005 - 22:00
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) announced the availability of its newest technical publication, “GAMP Good Practices Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures.”… Reshaping Pharmaceutical Quality
Tue, 06/10/2008 - 22:00
(ISPE: Tampa, Florida) -- The June 2008 issue of the Journal of Pharmaceutical Innovation (JPI) is publishing the first scientific papers outlining the progress made on the International Society for Pharmaceutical Engineering’s (ISPE) product…