Jose Rodriguez-Perez (Pepe)

eBook, ePUB

Handbook of Investigation and Effective CAPA Systems (eBook, ePUB)

Beschreibung

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 company Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 Updated inspectional observations from the U.S. FDA and U.K. MHRA A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process New charts and information related to the investigation of human errors; the human factor section includes information about training and competence A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results Updated 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 error Jose(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.

Technische Details

• Geräte: eReader
• mit Kopierschutz
• Größe: 4.65MB

Autor

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. Dr. Rodríguez-Pérez 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 Department at one of the Puerto Rico schools of medicine, and 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 he served as a Science Advisor for the FDA from 2009 to 2011. Dr. 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, The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals, Human Error Reduction in Manufacturing, and Data Integrity and Compliance, all available from ASQ Quality Press. Contact Dr. Rodríguez-Pérez at [e-mail].

Produktdetails

• Verlag: ASQ Quality Press
• Seitenzahl: 256
• Erscheinungstermin: 15. Februar 2022
• Englisch
• ISBN-13: 9781636940120
• Artikelnr.: 66250686