General

1. Learning management system used for training documents
7. SAP system used to receive materials at the warehouse
9. Quality system regulations 21CFR Part 820 Pertain to these products
12. A principle that ensures the first recording of data is available
13. Sterility assurance release program where demonstrated control of the sterilization process enables a firm to use defined critical process controls
14. A document that shows our commitment to Quality
15. The country where the Sanofi site sends Ridgefield Enoxaparin Sodium
17. An official inspection of an individual's or organization's system

2. A request to change any processes in manufacturing has to go through
3. Actions performed on data should be traceable to person who performed the actions
4. Sanofi Audit team that audits Ridgefield
5. The health authority that can issue 483s
6. Department that conducts calibration
8. Studies that are performed to visually confirm unidirectional airflow exiting High Efficiency Particulate Air HEPA
10. A list of suppliers that GMP supplies and services
11. A department that puts product in chambers for testing
14. An agreement between a vendor and the quality organization at Sanofi
16. The type of packaging that has direct contact with the drug