The Live webinar on Auditing Software Vendors & Service Providers for 21 CFR Part 11 2012 covers topics such as:
- 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
The Live webinar on Auditing Software Vendors & Service Providers for 21 CFR Part 11 2012 brings together:
- Software Developers
- Information Technology Directors & Management
- Software Quality Assurance Personnel
- Software Sales and Marketing professionals
- Auditors in FDA regulated industry
