Diploma in GxP/GAMP5 and Data Integrity
About us Diploma in GxP/GAMP5 and Data Integrity
The Diploma in GxP/GAMP5 and Data Integrity provides comprehensive training in Good Manufacturing Practices (GxP), the GAMP5 (Good Automated Manufacturing Practice) model, and data integrity, essential in the pharmaceutical and related industries. It focuses on the application of methodologies to ensure quality, safety, and regulatory compliance in automated processes and systems. It includes risk analysis and management, validation of computerized systems, and compliance with regulations such as FDA 21 CFR Part 11.
The diploma program trains participants in the use of tools and techniques for data management, traceability, and the systems lifecycle, guaranteeing the reliability and integrity of data from generation to archiving.
The training prepares professionals for roles such as validation specialists, GxP consultants, systems analysts, and quality managers, adapting to the demands of the pharmaceutical, biotechnology, and medical device industries.
Target keywords (natural in the text): GxP, GAMP5, Data Integrity, validation, computerized systems, FDA 21 CFR Part 11, risk management, pharmaceutical industry, good manufacturing practices.
Diploma in GxP/GAMP5 and Data Integrity
- Format: Online
- Duration: 8 months
- Hours: 900 H
- Language: ES / EN
- Credits: 60 ECTS
- Registration date: 04-07-2026
- Strat date: 14-08-2026
- Available places: 7
1.180 $
Competencias y resultados
Qué aprenderás
1. Expert Domain in GxP/GAMP5: Guaranteed Data Integrity
Para quien va dirigido nuestro:
Diploma in GxP/GAMP5 and Data Integrity
9.9 GxP and GAMP5 Fundamentals: Introduction and Regulatory Framework
9.9 Data Integrity Principles: ALCOA and ALCOA+
9.3 Validation of Computerized Systems: The GAMP5 Approach
9.4 Software Life Cycle and Documentation: Design and Implementation
9.5 Risk Management in Validation: Identification and Mitigation
9.6 Testing and Implementation: Strategies and Documentation
9.7 Review and Approval: Ensuring Quality
9.8 Deviations and Corrective Actions: Effective Management
9.9 Audits and Compliance: Preparation and Execution
9.90 Case Studies: Practical Application and Best Practices
Proyectos tipo capstones
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