Certificación IACET Quality risk Management

Esta certificación beneficiará  a los fabricantes de productos sujetos a ls requerimientos regulatorios de las Agencias de Medicamentos y Productos Sanitarios nacional e internacionales (FDA, AEMPS, EMEA, Anvisa, etc.) para evitar “findings” en las inspecciones de los citados organismos regulatorios. Excelente cualificación para los profesionales de Quality Asurance, Manufacturing, Regulatory Affairs, Supplier Quality and Quality Control  de empresas dedicadas a la fabricación de  productos farmacéuticos, biotecnológicos y productos sanitarios.

Nuestro director es:

José Rodríguez

Nuestro director es:

Biólogo y doctor en Inmunología por la Universidad de Granada. Es Presidente y CEO de Business Excellence Consulting (BEC), empresa de consultoría y formación en Regulatory compliance, Risk management y Operational Excellence en los sectores regulados por la FDA.

Carretera de Fuencarral, Km 22 Edificio Net-Pharma 28108 Alcobendas (Madrid)


Opening Remarks
Introduction to Quality Risk Management

What is Quality Risk Management?

ICH Q9/ISO 14971 Terminology

More than Safety Risks: From Safety Risks to Quality by Design

Principles of Quality Risk Management


Science and Risk-based Approaches of Product Quality

Quality Systems Approach

General Quality Risk Management Process

Introduction to Quality Risk Management Process /Responsibilities and Initiation of the Risk Management Process

Risk Assessment

Risk Control

Risk Documentation and Communication

Risk Monitoring and Effectiveness Review

Application of risk assessment during life cycle phases

Integration of Risk Management with Quality Management

Risk Management Plans

Practical Applications of Quality Risk Management to the Life
Science Manufacturing Industry

Management (audit, training, CAPA system, supplier selection and control, outsourcing, regulatory actions: Recalls Health Hazard Evaluation

Documents and Records / Change Management

Facilities and Equipment

Design and Development

Production and Process Control

Methodologies and Tools

Selection of risk assessment techniques

Application of risk assessment during life cycle phases

Risk assessment techniques

Methodologies and Tools

Selection of risk assessment techniques

Application of risk assessment during life cycle phases

Risk assessment techniques

Failure Mode and Effect Analysis (FMEA): the Fail-Safe FMEA

Introduction to the FMEA World

Failure Mode and Effect Analysis (FMEA): the Fail-Safe FMEA (cont.)

The FMEA Form

Failure Mode and Effect Analysis (FMEA): the Fail-Safe FMEA (cont.)

Best Practices: How to Perform an Effective FMEA

Final Words: FMEA Do’s & Don’ts

Practice Day


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.

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