Certifícate como experto internacional en Calidad

Certificación IACET Data Integrity

Este curso de certificación sobre Data Integrity beneficiará  a cualquier professional de Manufacturing, QC/QA, Desarrollo de Productos y  Analytical Development de cualquier Laboratorio dedicado al desarrollo, registro, fabricación y comercialización de productos farmacéuticos y afines (productos sanitarios, cosmética, etc.) y fabricantes de API. Auditores responsables de la realización de autoevaluaciones o auditorías externas se beneficiarán igualmente de esta certificación.

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
Learn the importance of Data Integrity

Define Data Integrity concepts, regulatory actions and requirements

Understand the ALCOA components

A look into the Good Documentation Practice

Data Integrity Roles and Responsibilities
Inventory Management
Use of Spreadsheets


Practice Exercise
Information Technology and Data Integrity
What are Electronic Records?

Electronic Record and Electronic Signatures (ERES) Regulations

How the ALCOA is applied to Electronic Records

Computerized System Validation – Risk Based Approach

End User Applications

Triggers for e-Data Integrity Loss

Introduction to Laboratory Perspective
Specifications and Standards

Sampling Plans

Test Procedures
Regulatory Observations
Laboratory Controls
21CFR211 requirement
Laboratory Records
Regulatory Observations
Good Documentation Practices
Analyst Function

Formats for laboratory data collection

Types of laboratory documents

Production and Process Controls
Materials Management
Regulatory Observations

Good Documentation Practices

Document Management


Quality Unit Responsibilities
Data Integrity Effort and Remediation



FDA Perspective on Data Integrity Remediation
Post Test


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.

Solicita más información