GMP NEWS 2000

FDA Requirements to Electronic Signatures and Records in the Laboratory

On 5-6 October 2000 CONCEPT HEIDELBERG in cooperation with the European Compliance Academy (ECA) organised a conference where current FDA requirements of 21 CFR Part 11 1 were discussed.

The following Questions and Answers come from the Panel Discussion and were put together by one of the most famous expertsin this field, Dr. Ludwig Huber (Hewlett Packard).

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3rd European GMP Conference on Active Pharmaceutical Ingredients - Review -

During the period from September 6 - 8, 2000 the 3rd European GMP Conference on Active Pharmaceutical Ingredients of APIC, a subgroup CEFIC, took place in Hamburg.

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