Manuel E. Peña-Rodríguez is a process improvement and training consultant with more than 20 years of experience. He also serves as professor in the graduate program in biochemistry at the University of Puerto Rico, Medical Sciences Campus, in San Juan. Manuel is a licensed Professional Engineer with a master degree in Engineering Management from Cornell University, and a J.D. He is an ASQ Certified Six Sigma Black Belt, Manager of Quality & Organizational Excellence, Quality Engineer, Quality Auditor and Biomedical Auditor, and an ISO 13485:2003 lead auditor. Also a senior member of ASQ and former Chair of the Puerto Rico 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 author of several peer-review articles covering topics such as risk management and sampling. He has been part of BEC Inc. since 2006.
Madeline Muñoz has over 20 years of experience in the pharmaceutical industry. She has held leading positions as Production Manager, QA Director and Quality Systems Director for a major pharmaceutical company. Her areas of expertise are warning letter remediation, complaint and manufacturing investigations, CAPA, change control, product disposition, gap assessments and FDA PAI readiness. Mrs. Muñoz has worked as a consultant, leading international projects helping clients pass FDA inspections with zero observations. She is an ISO 13485:2003 Lead Auditor and has been part of BEC Inc. since 2012.
Leslie Orama is a management system implementation and training consultant within the FDA-regulated industries with over 22 years of experience. She has a bachelor degree in Chemistry from the University of Puerto Rico. She also has a master degree in Environmental Planning from Metropolitan University, Puerto Rico. Since year 2017, she is fully devoted to consulting under BEC Inc, focusing on training of food, internal audit, quality system regulations, root cause and effective CAPA, and management systems implementation. She is a Certified Planner, ISO 9001 and ISO 22000 Lead Assessor.
Frances Cartagena is a consultant within the FDA-regulated industries with over 20 years of experience in operations and quality; managing areas such as Operational Excellence and CAPA. She has a bachelor degree in Chemistry from Interamerican University of Puerto Rico. She also has a master degree in Business Administration from University of Phoenix with a major in Technology Management. Her work covers training in root cause and effective CAPA, and Human Error workshops. She has working experience in consent decrees. She is an ASQ Certified Six Sigma Green Belt and Certified Quality Auditor, and ISO 13485:2003 Certified Lead Auditor, and part of BEC Inc. since 2013.