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News Release from: The Regulatory Compliance Workshop Group | Subject: IT compliance workshops
Edited by the Laboratorytalk Editorial
Team on 27 January 2004
US and European pharma IT compliance
workshops
Dates announced for the 2004 US and European pharma IT compliance workshops for all pharmaceutical, medical device and biotech companies working to GMP/GLP/GCP
The Regulatory Compliance Workshop Group announces dates for the 2004 US and European pharma IT compliance workshops for all pharmaceutical, medical device and biotech companies working to GMP/GLP/GCP The workshops include the following
The immediate impact of the US FDA's new guidance for industry on 21 CFR part 11, electronic records and electronic signatures.
Understanding and applying risk management to meet FDA requirements for computerised systems.
Auditing computerised systems to pass FDA and European regulatory inspections.
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