Data Integrity: FDA/EU Requirements and Implementation

Data integrity has been a focus for pharmaceutical regulatory inspections for a number of years and look set to remain of concern to regulators and manufacturers for many years to come. Many inspection reports from regulatory agencies around the world cite data integrity as a cause of observations and enforcement action, and actions taken by regulators to restrict the commercial activities of manufacturers on the grounds of data integrity violations have obvious serious consequences for the company concerned.

This 2-day online course explains the background to the data integrity regulations and sets out the expectations of pharmaceutical regulators. All the current data integrity guidances emphasize a risk-based approach to compliance, and the course explains how to evaluate and control data integrity risks. A key resource in relation to electronic records is GAMP 5, which deals with controlling risk and managing computerized systems over their life cycle. The practices recommended by GAMP 5 will be dealt with in detail, and practical advice on the appropriate use of Excel spreadsheets given. Data integrity should not be thought of as an exclusively analytical problem, and examples of data integrity violations in production will highlight the risks during manufacturing.

Learning Objectives:

Attendees will:

• Understand what data integrity is and why it is so important for patient safety
• Recognise that there are many causes of data integrity breaches
• Know the current regulatory expectations
• Appreciate the difference between static and dynamic records, and be able to apply acceptable strategies for the retention of both types of record
• Be able to categorise and validate GxP computerised systems according to GAMP 5
• Understand the importance of training and quality culture in avoiding regulatory enforcement action
• Learn how to respond to data integrity observations in inspection reports
• Learn how to prevent, detect and remedy data integrity problems

Who will Benefit:

• QA managers and personnel
• Laboratory managers and supervisors
• Production managers and supervisors
• Analysts
• IT/IS managers and system administrators
• Software developers
• Regulatory affairs
• Training departments
• Documentation departments
• Consultants
• Auditors