QUALITY
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)
Programa
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
Principles
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
Profesores
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.