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Labcompliance News, December 1998

Dec 1, 1998

FDA Industry Training on 21 CFR Part 11

The Food And Drug Administration (FDA) is announcing a meeting entitled "Industry Training on 21 CFR Part 11". The topics to be discussed are cGMP electronic recordkeeping requirements, validation of electronic record-keeping systems, and the answers to frequently asked questions on part 11.

The meeting will take place on Tuesday, January 12, 1999, 1 p.m. to 4 p.m

Dec 1, 1998

Article on Qualification of HPLC systems

BioPharm, Vol.11 Number 11, November 1998, pages 41 and 65/66
The article from Ludwig Huber describes steps required for the qualification of HPLC systems: Design qualification, installation qualification, operational qualification, performance qualification. To be as practical as possible, a real application scenario from a QA/QC laboratory is used. In case the reader has a different application, the templates can be used as described in this paper, however, the qualification parameters and acceptance criteria can be modified accordingly. Order from libraries or download draft version from LabCompliance User Club.