QUALITY
Certificación IACET CAPA (Corrective and Preventive Actions)
Esta certificación beneficiará a los fabricantes de poductos sujetos a ls requerimientos regulatorios de las Agencias de Medicamentos y Productos Sanitarios nacional e internacioneales (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
The Vicious Cycle
The Correct CAPA Flow
Root Cause Identification
The Closed-Loop CAPA Process
CAPA and the Regulations
Adulteration
CAPA in the Pharmaceutical / Medical Device Industry
The CAPA Link Between Pharmaceutical and Medical Devices
Combination Products and CAPA
Main FDA Findings
Eleven Opportunities of the CAPA System
Risk Management and CAPA
Introduction to Quality Risk Management
Regulatory Requirements
Risk Prioritization of Investigations
Integration of Risk Management and CAPA
Elements of an Investigation Report
Event Information / Description of the Issue
Immediate Actions Taken / Initial Impact Assessment
Investigation Details
Conclusions About Root Causes
CAPA Plan
Final Disposition and Approval / Executive Summary
Practice Exercise
Defining Corrections, Corrective Actions, Preventive Actions, Causal Factors, and Root Causes
Problem Solving Methodology
Focus of the Model
Defining the Problem
Chronological Analysis
Change Analysis
Searching for Trends / Searching for Correlation
Flowchart
Problem Solving Methodology (cont.)
Is/Is Not Matrix
Barrier Control Analysis
Causal Factor and Root Cause Identification
Practice Exercise
Problem Definition
Root Cause Analysis Tools
Fishbone
5 Whys
Fault Tree Analysis
Root Cause Categories
Elements of the CAPA Plan
Corrections, Corrective Actions, Preventive Actions
Generating Corrective and Preventive Actions
Effectiveness Evaluation
CAPA Effectiveness Examples
Practice Exercise: Writing Effectiveness Verification Statement
Introduction to Human Errors
Key Points to Consider
Latent Human Errors
Causal Factors and Root Cause Identification
Investigating Human Errors
How to Investigate Human Errors
Interviewing, Not Interrogating
Human Error Investigation Key Points
Human Error + Retraining
Training as Human Factor
How to Reduce the Probability of Human Errors
Areas to Focus
Practice Exercise: Human Error Investigation
Eleven Biggest CAPA Opportunities
Timeliness
Everything is an Isolated Event
Root Cause Not Identified
Correcting the Symptoms Instead of the Cause
Lack of Interim Corrective Actions
Root Cause Identified But Not Corrected
Lack of True Preventive Actions
Lack of Effectiveness Verification of Action Taken
Multiple CAPA Systems Without Correlation
Over-Customization of the CAPA System
Abuse of Human Error and Retraining
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
He 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.