Computer System Validation - Reduce Costs and Avoid 483s: 2-day In-person Seminar

Significant changes in the regulations and industry standards for software validation are detailed in this interactive two-day course. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation related to FDA 21 CFR Part 11, European Annex 11, and HIPAA electronic security regulations for patient medical records.

Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.

This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.

• Regulatory Affairs
• QA/ QC
• IT/IS
• Software Managers
• Project Managers