Ensuring 21 CFR 11 Compliance at Suppliers 2014 is a webinar that covers topics such as:
- 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
Ensuring 21 CFR 11 Compliance at Suppliers 2014 is intended for:
- Validation managers and professionals
- Quality managers and professionals
- Regulatory affairs managers and professionals
- IT managers and professionals
- Quality auditors
- Supplier quality professionals and managers
