Corrective and Preventive Actions (CAPA)
Description:
In this course we will discuss corrective and preventive action also called CAPA which are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice (GMP), and numerous ISO business standards that is critical to an organizations continuous improvement.
Curriculum for this course:
Introduction
| Agenda | 1 min 04 secs |
| Regulatory | 1 min 30 secs |
| Regulatory explanation | 1 min 50 secs |
| Only about compliance? | 56 secs |
| The Basics: CA | 45 secs |
| The Basics: PA | 1 min 45 secs |
| Key concepts | 1 min 30 secs |
| Systemic issues | 1 min 30 secs |
| Non-systemic issues | 1 min 40 secs |
| Systemic issues – product examples | 1 min 30 secs |
| Systemic issues – process examples | 52 secs |
Module 1: Industry
| Industry [Non]Compliance | 1 min 02 secs |
| Process Requirements | 1 min 23 secs |
| Process Requirements: FDA | 1 min 23 secs |
| Process Requirements: ISO 13485 | 1 min 30 secs |
Module 2: Sources
| Sources | 1 min 48 secs |
| Risk: Helping you manage | 1 min 05 secs |
| The process | 1 min 19 secs |
| First things first: understand | 1 min 17 secs |
| Containment | 1 min 19 secs |
| Scope analysis: Food for thought | 1 min 30 secs |
Module 3: Root Cause Analysis
| Root cause analysis (definition) | 1 min 30 secs |
| Root cause analysis – why? | 2 min 30 secs |
| Root cause analysis: toolbox | 1 min 40 secs |
| Root cause analysis: example | 1 min 01 secs |
| Root cause analysis: example (5 Whys) | 1 min 39 secs |
| The results | 1 min 45 secs |
| Root cause analysis: Major tripping point | 1 min 23 secs |
| Root cause analysis: final thoughts | 1 min 50 secs |
Module 4: Actions
| Action | 1 min 23 secs |
| Actions: more than just “To Do” | 52 secs |
| Actions: A Tripping Point | 50 secs |
Module 5: Review
| Review | 1 min 02 secs |
| Management Review Input | 39 secs |
| Actions > Effectiveness > Transition | 1 min 02 secs |
Module 6: Effectiveness
| Effectiveness: expectations | 2 min 30 secs |
| Effectiveness | 1 min 30 secs |
| Effectiveness: simple? | 1 min 20 secs |
| Actions / effectiveness: example 1 | 1 min 23 secs |
| Actions / effectiveness: example 2 | 1 min 30 secs |
| Inspection / audit focus | 52 secs |
| Take-aways | 1 min 02 secs |
| The future | 1 min 02 secs |
| Conclusion | 1 min 23 secs |
Conclusion
Final Exam
Certification
Revision History
| Updates to fix course functionality | V2.1 |
| Redesigned course with new Articulate Storyline player | V2.0 |
| Added new Review Activities | V2.0 |
| Added new final exam question to align with learning objectives | V2.0 |
| Updated Glossary links | V2.0 |
Author:
General Info:
-
CEU Credits: 0.1 -
Course code: ELM-117 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes -
version: V2.1 -
Effective Date: 01/10/2021
Reviews:
Finally a way to explain the CAPA process to new hires and a great refresher for existing staff.
Excellent course and straight to the point
Really enjoy this style of learning and love the pop quizzes throughout.
We’ve incorporated this course into our own QMS as a must do learning module.
Love the approach of example based learning – great job guys.
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How to Manage Deviations in a GMP Environment – Part 1
Laboratory Investigations & Deviations
How to Write Effective Standard Operating Procedures (SOPs)
Implementing Compliant Systems in the Cloud
Contamination Control Strategies in a GMP Environment
How To Be An Effective GMP Auditor – Part 3
How to be an Effective GMP Auditor – Part 2
How to be an Effective GMP Auditor – Part 1
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