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.

Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential. This explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Students learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation. Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline SOP authoring, revision, review, and approval.

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.

• Understand what is expected in Part 11 and Annex 11 inspections
• Implement a computer system to gain maximum productivity and reduce cost by as much as two thirds
• Quickly cross train workers and see how to make use of temporary workers and outsourcing to promote growth and reduce costs
• "Right size" change control methods that allows quick and safe system evolution
• Minimize the validation documentation to reduce costs without increasing regulatory or business risk
• Write test cases that trace to elements of risk management
• Protect intellectual property and keep electronic records safe

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
• Software vendors and suppliers