Understanding and improving the CAPA system as a whole is the focal point of this book, the only of its kind dealing exclusively with this critical system within highly regulated industries. Features include:
~Information about the importance of the CAPA system within the quality system for the medical products regulated industry. ~Fully updated with current versions of regulations (U.S. FDA, EU, ISO 13485, and so on), and a new section covers the regulatory expectation of customer complaint investigations. ~Investigation and CAPA elements of the 2015 revision of the ISO 9001 standard. ~New coverage on the investigation plan and the new U.S. FDA quality metric guidance, as well as a section discussing the tight relationship between CAPAs and FMEA. ~A new chapter fully devoted to human errors and human factors, and their impact in the investigation and CAPA system. ~Discussion of a dozen of the most common pitfalls commonly encountered in the investigation and CAPA world of regulated companies. ~An example of an investigation and CAPA expert certification program being used for many companies. ~Forms and examples of the different elements (investigation report, root causes checklist, human error investigation, CAPA plan, and so on) covered in the book. Fully usable forms are also included in the companion CD in Microsoft Word format.
While the first edition of this book was aimed solely at the FDA-regulated industry, the title of this second edition reflects the importance of the investigation/root cause analysis stage as the necessary preceding step of any effective corrective and preventive action system. Investigation and CAPA are concepts used in many sectors besides the FDA-regulated industry, such as: automotive, electronics, aerospace, telecommunications, process industry, and many more. This book will become an essential reference for those in these other industries.
Dr. José (Pepe) Rodríguez-Pérez is the president of Business Excellence Consulting Inc. (BEC), a Puerto Rico-based, global consultant, training and remediation firm in the areas of regulatory compliance, risk management, and regulatory training in the FDA-regulated sector. He s also president of BEC Spain. He is a biologist and earned his doctoral degree in biology from the University of Granada (Spain). He served as professor and director of the Microbiology Dept. at one of the Puerto Rico schools of medicine. He also served as Technical Services manager at a manufacturing plant of Abbott Laboratories in Puerto Rico. From 2003 to 2012, he was professor for graduate studies of the Polytechnic University of Puerto Rico, and served as a Science Advisor for the FDA from 2009 to 2011. Rodríguez-Pérez is a senior member of ASQ, as well as a member of AAMI, ISPE, PDA, and RAPS. He is an ASQ-certified Six Sigma Black Belt, Quality Manager, Quality Engineer, Quality Auditor, Quality HACCP Auditor, Biomedical Auditor, and Pharmaceutical GMP Professional. He is also the author of the best-selling books CAPA for the FDA-Regulated Industry, Quality Risk Management in the FDA-Regulated Industry, and The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals, all available from ASQ Quality Press.
