How 21 CFR Part 11, the FDA regulation pertaining to use of electronic records and signatures, and the HIPAA electronic security regulations for patient medical records fit into the validation process
The latest computer system industry standards for data transfer, data security, and audit trails
How to streamline SOP revision, authoring, approval and review
Recent FDA inspection trends
Who should Attend
Clinical, regulatory and IT professionals working in the clinical trial, health care, medical device and biopharmaceutical sectors.
Past Events
Computer System Validation - Reduce Costs and Avoid 483 2015 - 19-20 Oct 2015, Sao Paulo, Brazil (53628)
Computer System Validation - Reduce Costs and Avoid 483 2026
Important
Please, check "Computer System Validation - Reduce Costs and Avoid 483" official website for possible changes, before making any traveling arrangements
Event Categories
Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Pharma
Technology: Biotechnology, Information Technology (IT)
