Table of Contents for CAPA for the FDA-Regulated Industry


List of Figures and Tables
ix
Preface xiii
Chapter 1 The Quality System and CAPA
1(8)
1.1 The Quality System and CAPA
1(3)
1.2 CAPA Relationship With Other Quality Subsystems
4(2)
1.3 Corrective or Preventive?
6(3)
Chapter 2 CAPA and the Life Sciences Regulated Industry
9(22)
2.1 FDA Pharmaceutical CGMP
10(1)
2.2 FDA Medical Devices QSR
11(2)
2.3 FDA Quality System Inspection Technique (QSIT), 1999
13(6)
2.4 FDA Guidance: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production, 2006
19(2)
2.5 FDA Guidance: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, 2006
21(2)
2.6 European Pharmaceutical GMP (EudraLex Volume 4), 2003
23(1)
2.7 Harmonization Processes: ICH and GHTF
24(1)
2.8 ICH Q10: Pharmaceutical Quality System, 2008
25(1)
2.9 ISO 13485:2003 and Non-U.S. Medical Devices Regulations
25(2)
2.10 GHTF Quality Management System---Medical Devices---Guidance on Corrective Action and Preventive Action and Related QMS Processes, 2009
27(1)
2.11 Current FDA Regulatory Trends for the CAPA System
28(3)
Chapter 3 Effective CAPA Process: From Problem Detection to Effectiveness Check
31(58)
3.1 Problem Detection: Discovering Problems
33(13)
3.1.1 Source of Data About Product and Quality Issues
33(2)
3.1.2 Risk Assessment
35(7)
3.1.3 Initial Impact Assessment
42(1)
3.1.4 Process Trending
43(3)
3.2 Problem Investigation: Discovering Root Causes
46(30)
3.2.1 Symptoms, Causal Factors, and Root Causes
47(3)
3.2.2 Problem Description
50(5)
3.2.3 Barrier Analysis
55(1)
3.2.4 Root Cause Identification Processes and Tools
56(4)
3.2.5 Root Cause Categories
60(2)
3.2.6 Investigating Human Errors
62(14)
3.3 CAPA Plan: Corrective and Preventive Actions to Fix Root Causes
76(3)
3.3.1 Establish Effective Corrective and Preventive Actions
76(1)
3.3.2 Validation and Verification Prior to Implementation
77(1)
3.3.3 Implementation of Corrective and Preventive Actions
78(1)
3.4 Effectiveness Evaluation
79(5)
3.4.1 Verifying That Solutions Worked
79(1)
3.4.2 Training Effectiveness
80(4)
3.5 Management of the CAPA System
84(5)
3.5.1 CAPA System Structure
85(1)
3.5.2 CAPA Process Metrics
85(1)
3.5.3 Risk Management and the CAPA System
86(1)
3.5.4 Management of External CAPA
87(2)
Chapter 4 Documenting CAPA
89(4)
4.1 Content of the Investigation Report / CAPA Plan Report
89(2)
4.2 Compliance Writing
91(2)
Chapter 5 The Ten Biggest Opportunities of the CAPA System and How to Fix Them
93(12)
5.1 Timeliness (Lack of)
93(3)
5.2 Everything is an Isolated Event (Lack of Adequate Trending)
96(2)
5.3 Root Cause Not Identified
98(1)
5.4 Correcting the Symptoms Instead of the Cause
99(1)
5.5 Lack of Interim Corrective Actions
100(1)
5.6 Root Causes Identified but Not Corrected
100(1)
5.7 Lack of True Preventive Actions
101(1)
5.8 Lack of Effectiveness Verification of the Action Taken
102(1)
5.9 Multiple CAPA Systems Without Correlation
103(1)
5.10 Abuse of Human Error and Retraining
103(2)
Chapter 6 Developing an Internal CAPA Expert Certification
105(8)
6.1 Content of the Certification
105(4)
6.2 Evaluating the Effectiveness of Internal CAPA Training Efforts
109(1)
6.3 CAPA Certification Exam Example
110(3)
Chapter 7 CAPA Forms
113(12)
7.1 Event Description and Investigation
114(2)
7.2 CAPA Plan
116(2)
7.3 Investigation Report and CAPA Assessment Form
118(4)
7.4 Human Error Investigation Form
122(3)
Chapter 8 CAPA Final Recommendations
125(2)
Appendix A
127(2)
Additional Resources
127(1)
Useful Web Sites
127(2)
Acronyms 129(2)
Glossary 131(6)
Bibliography 137(4)
Index 141