This online training program describes corrective and preventive actions (CAPAs), and how good manufacturing practices can be applied to eliminate causes of non-conformities or other undesirable situations. The training program enables the students to interpret and identify the requirements of a pharmaceutical CAPA system. As a fundamental management tool, CAPA is integral to the effectiveness of a quality management system. The objectives of this course are to teach the requirements of ICH Q10- PQS (Pharmaceutical Quality System), describe escalation and tracking processes in a CAPA system, explain the importance of investigation and risk assessment, list a CAPA system's critical elements, explore the different processes and phases of a good CAPA system, and identify a CAPA system's regulatory requirements.
·Identify the regulatory requirements for a CAPA system.
·List the various phases and the processes of a successful CAPA system.
·Explain the critical elements of a CAPA system.
·Explain the importance of risk assessment and investigation.
·Describe tracking and escalation processes in a CAPA system.
·Recognize the requirements of ICH Q10 - Pharmaceutical Quality System (PQS).
4. Pharmaceutical Quality System (PQS) Model
5. Key areas of the QMS
6. Reviews and assessments
8. Compliant CAPA systems
9. Activity: Looking for CAPA requirements within GMPs
10. FDA QSIT inspections of CAPA systems
11. Important definitions
12. Examples of different CAPAs
13. Topic review
THE CAPA SYSTEM
15. Features of a CAPA system
16. CAPA flowchart
17. Phases of a CAPA system
18. Topic review
ELEMENTS OF CAPA SYSTEMS
20. CAPA system inputs
21. Risk assessment and CAPA
22. Risk assessment process
23. CAPA documentation
24. The CAPA procedure
25. CAPA request/record
27. Corrective action
28. Preventive action
29. Verification and closeout
30. Completed CAPA report
31. Topic review
ROOT CAUSE ANALYSIS
32. Symptom or Root Cause?
33. When to conduct RCA/CAPA
34. Root Cause Analysis (RCA)
35. Investigation & Analysis
TRACKING AND ESCALATION
37. Progress tracking and escalation
38. CAPA trending
39. Topic review
Duration: 90 Minutes
Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version
Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.