Description
Data Integrity is a core requirement in all regulated industries — especially pharmaceutical manufacturing where decisions, batch release, compliance, and patient safety depend on accurate, complete, and trustworthy data.
This course provides a comprehensive, practical understanding of Data Integrity principles, ALCOA+ standards, and Data Governance frameworks according to FDA, EMA, MHRA, WHO, and PIC/S expectations.
Participants will learn how to identify, prevent, and manage data integrity risks in both paper-based and electronic systems, including laboratory instruments, LIMS, ERP, MES, QMS, and production records.
The training covers documentation practices, system controls, audit trails, cybersecurity interfaces, validation expectations, and how to build a robust Data Governance system that ensures ongoing compliance.
Through case studies, real inspection examples, and practical scenarios, trainees will understand how inspectors detect data issues and how organizations should respond and correct them.
By the end of this course, participants will be able to:
- Understand global Data Integrity regulatory requirements
- Apply ALCOA+ principles to all data types
- Detect data integrity gaps and high-risk behaviors
- Implement Data Governance and ownership roles across departments
- Evaluate audit trails and electronic records controls (ERES / 21 CFR Part 11)
- Build preventive systems that ensure accurate, complete, consistent, and secure data
- Strengthen inspection readiness for GMP audits and regulatory reviews
- Reduce compliance risks across QC labs, production, engineering & documentation flows
Who Should Attend
- This course is ideal for professionals dealing with data, documentation, and compliance in any regulated environment, including:
- Quality Assurance (QA)
- Quality Control (QC) & Microbiology Labs
- Production & Manufacturing Teams
- Regulatory Affairs & Compliance Officers
- Validation, CSV & IT/Automation Specialists
- Engineering , IT& Maintenance Teams
- Documentation Centers / Archiving Units
- Fresh graduates entering GMP roles and needing DI awareness
- Any employee generating, reviewing, approving, or storing GMP data
Key Takeaways
- Flexible Attendance Options – Join in-person at VALOR or virtually through our live interactive platform.
- Recorded Sessions – Enjoy limited access to recordings for one month after course completion for review and reinforcement.
- Repeat for Free – Participants may re-attend inperson any future round of the same course at no additional cost.
- Accredited Certificate – Receive a QR-coded certificate for authenticity verification and professional recognition.
- Comprehensive Resources – Access digital materials, trainer support, and post-course assessments through VALOR’s e-learning platform
Number Of Sessions
2 Sessions