Many regulated companies are still using unvalidated or poorly validated computer systems. Computer system validation is required by the FDA as well as ISO 13485.  This webinar will review the FDA's  Final Guidance on Computer Software Assurance, which describes CSA as a patient / user risk-based approach to establish confidence in the automation used for production or quality management systems.  It further identifies where additional rigor may be appropriate; and  describes various methods and testing activities that may be applied to establish CSA and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in quality management system obligations, including requirements in 21 CFR Part 820 / ISO 13485, also including Cybersecurity and Part 11 requirements.

This webinar benefits the following agencies:

• Pfizer, GlaxoSmithKline, Merck & Co., Bayer, etc.
• ISPE, AShMIE, ASQ, RAPS, etc.

Who should attend?

• This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include: 
• End-users responsible for applications that need to be validated
• QA managers and personnel 
• Information Technology managers and personnel 
• Validation specialists 
• Consultants 
• Quality system auditors