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
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
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