Este curso de certificación sobre Data Integrity beneficiará  a cualquier professional de Manufacturing, QC/QA, Desarrollo de Productos y  Analytical Development de cualquier Laboratorio dedicado al desarrollo, registro, fabricación y comercialización de productos farmacéuticos y afines (productos sanitarios, cosmética, etc.) y fabricantes de API. Auditores responsables de la realización de autoevaluaciones o auditorías externas se beneficiarán igualmente de esta certificación.

Nuestro director es:

José (Pepe) Rodríguez

Pepe Rodríguez is founder and President of Business Excellence Consulting Inc., a leading Puerto Rican training and consulting organization. From 2009-11 he served as a Science Advisor for the FDA San Juan District. He has served as instructor of courses on quality and continuous improvement in several countries with thousands of professionals trained in topics such as Quality Engineering, Six-Sigma, Effective CAPA and Root Cause Analysis, HACCP and Quality Management. Pepe holds a bachelor’s degree in biology and PhD in immunology, both from the University of Granada, Spain. He served as a senior member of the American Society of Quality and President of the Puerto Rico (ASQ 1500) section during the period 2003-05. He was secretary from 2005-2012.

He is also a member of the Regulatory Affairs Professional Society (RAPS), ISPE, AAMI, and the Parenteral Drug Association (PDA). Pepe 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 & Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals”, published by the American Society for Quality.

Manuel E. Peña-Rodríguez

Manuel is a process improvement and training consultant within the textiles, electronics, and FDA-regulated industries with more than 20 years of experience in those fields. Since January 2006, he is fully devoted to consulting under Business Excellence Consulting Inc, focusing on training and implementation of Lean Six Sigma initiatives and CAPA / Root Cause Analysis workshops. He also serves as professor in the graduate program in biochemistry at the University of Puerto Rico, Medical Sciences Campus, in San Juan. Manuel received his J.D. degree from the Pontifical Catholic University of Puerto Rico and his master’s of engineering in Engineering Management from Cornell University in Ithaca NY. He is also a licensed Professional Engineer registered in Puerto Rico. Manuel is an ASQ Certified Six Sigma Black Belt, Manager of Quality & Organizational Excellence, Quality Engineer, Quality Auditor, Biomedical Auditor, and HACCP Auditor. He is also a Senior member of ASQ and former Chair of the Puerto Rico ASQ Section. He is the author of the book “Statistical Process Control for the FDA-Regulated Industry”, published by ASQ Quality Press in April 2013 and co-author (with José Rodríguez-Pérez) of the article “Fail-Safe FMEA” published in the January 2012 edition of the ASQ Quality Progress magazine.