Topics
- 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.
