Data Integrity Auditor Masterclass Training Course

Course overview

Over the past decade, data integrity has become the number one focus in regulatory inspections - and it’s showing no signs of slowing down. While the topic has only recently taken centre stage, its roots stretch back 30 years, with early breaches at Barr Laboratories and Able highlighting just how long-standing and serious the issue truly is.

As health authorities continue to scrutinise data integrity during audits, especially GMP audits, pharmaceutical manufacturers are under increasing pressure to ensure their internal teams are well prepared.

This intensive two-day course, delivered through practical guidance and real-world examples, explores data integrity through the lens of GxP audits. You’ll gain a clear understanding of regulatory expectations, the core concepts and guidelines, and what auditors need to know to uncover deficiencies before the authorities do.

Participants will explore which departments require data integrity auditing - from warehouse and production to quality control, quality assurance, engineering, and critical utilities. Sample audit questions, common findings, and real case studies bring the learning to life, ensuring you leave equipped to carry out confident, effective audits.

Whether you're building an audit-ready culture or sharpening your team’s inspection-readiness, this course will give you the tools and insight to make a measurable impact.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

• Learn exactly what health authorities expect from data integrity audits and how to meet those requirements
• Evaluate the concept of data integrity from a fresh, practical, and audit-focused perspective
• Understand the role of the data integrity auditor and the essential skills needed to perform effectively
• Discover how to audit and prepare for external inspections across key departments, including warehouse, manufacturing, quality control, quality assurance, critical utilities, and engineering

At the end of the course, there will be a short assessment exam featuring case studies and audit scenarios that will have been analysed during the training. Delegates who successfully pass the assessment will receive the title of ‘Certified Data Integrity Auditor’.

Who should attend?

Personnel from the following departments will benefit from this course:

• Quality assurance and quality control
• Validation
• R&D
• Audit
• Regulatory
• IT
• Warehouse and supply chain
• Engineering
• Procurement 

As well as:

• Health authority inspectors

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