Live webinar on Auditing Software Vendors & Service Providers for 21 CFR Part 11 2012

Topics

• For 21 Part 11
• Basic terminology - Why software vendor auditing is necessary and expected
• Physical audit vs "desktop" audits
• For Annex 11 - audit approaches – pros and cons of each
• Discussion of audit standards
• Supplier assessment questionnaires
• General principles of software validation
• Part 11 final rule
• Planning the audit: The Importance of intended use and predicate rules
• Software used to support clinical trials
• Key Part 11 focus areas, what to expect
• Areas common to all qualification audits
• Common mistakes to avoid
• How to prepare

Who should Attend

• Software Developers
• Information Technology Directors & Management
• Software Quality Assurance Personnel
• Software Sales and Marketing professionals
• Auditors in FDA regulated industry