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)


Opening Remarks

The Vicious Cycle

The Correct CAPA Flow

Root Cause Identification

The Closed-Loop CAPA Process

CAPA and the Regulations


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


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


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


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


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


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.

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