Curriculum

1. Process of Audit, annual and planned audit, check list, questions, follow up , review acceptance, CAPA management, Score , Result and reports
2. It is a program providing global management of PSMF file in the pharmacovigilance department – specific to QPPV and Pharmacovigilance officer in charge
3. Course runs details of monitoring the scientific RMP creation, review, approval and amendment
4. Details of quality management systems specific to world wide pharmaceutical practice
5. Review the details of SOP required in the process of PSMF and ensuring compliance
6. Complete manpower management review and check list
7. Auditing of Product dossier management of global marketing system SmPC , PIL,HIL, SIL,
8. Auditing Adverse events complete process management
9. Report submission, Individual case and periodic safety report
10. IT system management of PSMF
11. Audit internal coordination
12. Training coordination
13. IT coordination
14. Regulatory reply
15. Call centre
16. International inspection coordination and reply to queries

• Provide full examples of the each section of PSMF Audit check list
• Scoring methods
• Help with section wise SOP and contents needed for the each part as compliance
• Teaching include each section definition terminology examples,
• Online access to the training material
• Tutor interaction on request
• Certification on each module completion (on request)
• With course completion certification

• • Audit of Pharmacovigilance system master file introduction
  • Audit of process related to E collection, processing and reporting of individual case safety reports
  • Audit of periodic safety updates
  • Audit of Quality management systems at marketing authorization holder organization
  • Audits and inspections of pharmacovigilance systems for MAH
  • Audit of actions items in Risk Management plan
  • Audit of manpower, IT and training

Course Currilcum