President, Business Excellence Consulting Inc
José (Pepe) Rodríguez-Pérez, holds a bachelor’s degree in biology and a PhD in immunology, both from the University of Granada, Spain, its post-graduate studies in medical sciences. During his 30 years of career, he spent over 15 years working in a manufacturing plant of medical devices. He also was a Science Advisor for the U.S. FDA from 2009 to 2012. He founded Business Excellence Consulting Inc. in May 2005 and since then has been leading its operation and expansion to a global consulting firm. He served as a senior member of the American Society of Quality and Chair of the Puerto Rico section during the period 2003-05. He was secretary from 2005 to 2012. Pepe holds seven American Society of Quality (ASQ) certifications: Certified Six Sigma Black Belt, Manager of Quality & Organizational Excellence, Quality Engineer, Quality Auditor, HACCP Auditor, Pharmaceutical GMP Professional, and Biomedical Auditor. He is also a member of ISPE, ISPE, AAMI, and PDA.
He is the author of six best-selling books (published by ASQ-Quality Press) covering FDA topics: CAPA for the FDA - Regulated Industry (2010), Quality Risk Management in the FDA-Regulated Industry (2012), The FDA & Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals (2014), the Handbook of Investigation and Effective CAPA Systems (2016), Quality Risk Management in the FDA-Regulated Industry 2nd edition (2017), Human Error Reduction in Manufacturing (2018), and Data Integrity and Compliance (2019). He is also author of peer-review articles covering topics such as risk management, CAPA system, and data integrity.