CGMP: Pharmaceutical CAPAs (GMP10)

Kelly Thomas

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$249


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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.

               

COURSE OBJECTIVES:

·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).

COURSE OUTLINE:

INTRODUCTION

1. Welcome

2. Introduction

3. Overview

4. Pharmaceutical Quality System (PQS) Model

5. Key areas of the QMS

6. Reviews and assessments

 

REGULATIONS

7. Overview

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

14. Overview

15. Features of a CAPA system

16. CAPA flowchart

17. Phases of a CAPA system

18. Topic review

 

ELEMENTS OF CAPA SYSTEMS

19. Overview

20. CAPA system inputs

21. Risk assessment and CAPA

22. Risk assessment process

23. CAPA documentation

24. The CAPA procedure

25. CAPA request/record

26. Correction/containment

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

36. Overview

37. Progress tracking and escalation

38. CAPA trending

39. Topic review

40. Summary

 

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


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Speaker: Kelly Thomas, Vice President, Americas Quality Operations

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.




Get in touch

(315) 632-0735,
(315) 750-4379