REGULATORY COMPLIANCE SECTION TRAINING 2012

S. No.
1. 2. 3.

Topic
Certificate of Analysis for Local and Export Documentation of Quality Control Department Dossier Preparation

Trained By (a)

Trainee (b)

Date
03-05-2012 03-05-2012 24-05-2012, 31-05-2012, 07-06-2012 & 14-06-2012

Status
Completed Completed Completed

4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17.

Export Country Guidelines Microbial Attributes Packaging Data Method Validation Data Stability Data Batch Analysis Report Supply Chain Data Requisition for C.O.As Regulatory Affairs Requisition for C.O.As Working Standard Preparation Reference Standard From USP CoPP, P.D and Q.C Specification WHO Guidelines and Requirements Testing Method Writing Procedure Emailing, Coordinating with Supply Chain and Regulatory Affairs 14-06-2012 14-06-2012 14-06-2012 14-06-2012 14-06-2012 14-06-2012 14-06-2012 14-06-2012 14-06-2012 14-06-2012 Completed Completed Completed Completed Completed Completed Completed Completed Completed Completed

18. 19.

Regulatory Guidelines CPAR (Corrective Prevention Action Report)

a- Ahsaan Ahmed b- Sajid Naeem