Ensuring 21 CFR 11 Compliance at Suppliers 2014

Key Topics

• Types of supplier-provided data FDA reviews under its Application Integrity Policy
• How 21 CFR 11 ("Part 11") inter-relates with other FDA regulations
• Elements of a supplier-provided computer validation protocol that FDA will accept
• List of sampling methods FDA will accept when reviewing supplier-provided data
• Records to retain to show FDA that your supplier Part 11 oversight met FDA expectations
• Red flags that indicate a supplier’s data integrity is failing
• Ips for when you are planning to outsource device production and/or clinical testing
• FDA concerns of around your oversight of a supplier’s computer validation activities
• SOPs and policies you need to have
• How to handle suppliers maintaining your data

Who should Attend

• Validation managers and professionals
• Quality managers and professionals
• Regulatory affairs managers and professionals
• IT managers and professionals
• Quality auditors
• Supplier quality professionals and managers