Medical devices, biopharmaceutical, and traditional drug manufacturing companies devote an important part of their resources to dealing with incidents, investigations, and corrective and preventive actions. The corrective and preventive action system is known as the CAPA system. It is second to none in terms of frequency and criticality of its deviations, and most of the regulatory actions taken by the FDA and foreign regulators are linked to inadequate CAPA systems. This guidance book provides useful and up-to-date information about this critical topic to thousands of engineers, scientists, and manufacturing and quality personnel across the life sciences industries. Understanding and improving the CAPA system as a whole is the focal point of this book, the first of its kind dealing exclusively with this critical system within this highly regulated industry. By helping those in this industry improve their CAPA systems, it will be a crucial aid in their mission of producing safe and effective products.
Content:
Front Matter
• List of Figures and Tables
• Preface
• Table of Contents
1. The Quality System and CAPA
2. CAPA and the Life Sciences Regulated Industry
3. Effective CAPA Process: From Problem Detection to Effectiveness Check
4. Documenting CAPA
5. The Ten Biggest Opportunities of the CAPA System and How to Fix Them
6. Developing an Internal CAPA Expert Certification
7. CAPA Forms
• 8. CAPA Final Recommendations
Appendix A
• Acronyms
• Glossary
• Bibliography
Index
• Belong to the Quality Community!
• ASQ Membership
• ASQ Certification
• ASQ Training