Handbook of Investigation and Effective CAPA Systems

Jose (Pepe) Rodriguez-Perez

• Publisher: ASQ Quality Press
• Year: 2022
• Print ISBN: 9781636940113
• eBook ISBN: 9781636940120
• Edition: 3
• Topic: Business
• Subtopic: Food Industry
• Index: Business

Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the 'usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs.Enhancements to this third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the companyFully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485Updated inspectional observations from the U.S. FDA and U.K. MHRAA revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis processNew charts and information related to the investigation of human errors; the human factor section includes information about training and competenceA new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing resultsUpdated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human errorJose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.

Table of contents

• Cover
• Title page
• CIP data
• Preface to the Third Edition
• Acknowledgments
• Chapter 1. The Quality System and the Investigation and CAPA Element
• Chapter 2. Investigation and CAPA Requirements for the Life Sciences–Regulated Industry
• Chapter 3. ISO 9001:2015: Nonconformance and CAPA Requirements
• Chapter 4. Effective Investigation and CAPA Processes: From Problem Detection to Effectiveness Check
• Chapter 5. Human Error Investigation and Reduction
• Chapter 6. Laboratory Investigations
• Chapter 7. The Biggest Opportunities of the Investigation/CAPA System and How to Fix Them
• Chapter 8. Developing an Internal Investigation and CAPA Expert Certification
• Chapter 9. Documenting Investigation and CAPA: Forms and Examples
• Appendix A
• Acronyms
• Glossary
• References
• About the Author