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Labcompliance News, March 2007

January 12, 2007

New Video Presentation: How to Prepare Your Organization for the 'New' Part 11

In 1997 the United States Food and Drug Administration (FDA) issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. However, this first release was almost impossible to implement. Therefore the FDA plans to release a new version in 2007. However, the industry is unsure what to do and what the changes will be. Watch the new Labcompliance video with Ludwig Huber tom learn what's coming and receive a tool kit for easy implementation.

January 12, 2007

USP Chapter 1058 (Analytical Instrument Qualification) Close to Final Version

The United States Pharmacopeia has developed guidelines for qualification of analytical instruments. Since the first draft in January 2005 three more revisions have been released. The last revision has been published in USP's Pharmacopeial Forum 32(6). The deadline for inputs is February 15, 2007. If there are no major inputs, the final version will be released in USP 31. With this new USP chapter the 4Q-Model will become formal for analytical equipment qualification. Some other issues related to equipment qualification have been clarified as well. In a new Labcompliance audio seminar you can learn about the basic USP requirements. The seminar will also provide most recent information on changes since the first revision. In addition, attendees get tools such as SOPs and examples for easy implementation. For more information and registration, click here.