Course Overview:

Effectively managing deviations is essential to maintaining productivity and a stable GMP environment. However, many investigations end with “human error” as the root cause, resulting in repetitive actions such as retraining or procedural updates. While these may offer temporary relief, they often fail to address deeper behavioural and systemic issues—leading to recurring non-compliances.

This course introduces Behavioural GMP (bGMP) as a practical framework for understanding why non-compliance occurs—whether due to unintentional mistakes or deliberate actions—and provides effective strategies to prevent recurrence. Participants will examine key human error types, understand where retraining is genuinely useful, and recognise its limitations when underlying behavioural factors are not addressed.

On Day 2, the focus shifts to Data Integrity (DI), a core pillar of regulatory compliance and a critical component of an effective Quality Management System. The session explores DI principles, global regulatory expectations, and practical methods for ensuring data reliability across the pharmaceutical lifecycle, including QC and other operational areas. Real examples and case studies will guide participants in identifying, preventing, and responding to DI issues.

Course Outline:

Day 1: Behavioural GMP & Managing Deviations

• Root causes of product defects
• Human error types and underlying causes
• Behavioural drivers leading to non-compliance
• Managing errors and non-compliant behaviours
• Human learning stages and related error patterns
• Identifying behavioural and systemic contributors
• Building a strong quality culture and reducing recurring issues
• Leadership roles in reinforcing compliance
• Strategies to minimise learning and inherent errors
• Targeted approaches for preventing future errors

Day 2: Data Integrity

• Core principles and contributors to Data Integrity
• Regulatory expectations for data governance and security
• Assessing data criticality, risk, and controls
• Embedding DI into the QMS using a risk-based framework
• Protecting raw data and original records
• Practical DI audit techniques, detection methods, and remediation strategies

Participants

This program is designed for executives, managers, specialists, and supervisors involved in GMP compliance, deviation investigation, quality oversight, operations, and continuous improvement. Participants will gain practical tools and insights to strengthen GMP performance, reduce recurring issues, and uphold robust data integrity across their organisations..