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
US and European pharma IT compliance workshops 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.
