Course Outline:

Module 1: Introduction to GDP and Regulatory Requirements

• Overview of Good Distribution Practice (GDP)
• Key global regulatory frameworks (WHO, EU GDP, FDA, MHRA)
• Legal responsibilities and compliance obligations
• Case Study: GDP violations and regulatory penalties

Module 2: Preparing for GDP Audits and Inspections

• Types of GDP audits: internal, external, and regulatory inspections
• GDP audit checklist and documentation requirements
• Common audit findings and how to address them
• Practical Exercise: Conducting a mock GDP audit

Module 3: Risk Management in GDP Compliance

• Identifying and assessing risks in distribution practices
• Implementing a risk-based approach to GDP compliance
• CAPA implementation and continuous improvement
• Real-life Project: Developing a risk mitigation plan

Module 4: Supply Chain Integrity and Quality Management

• Ensuring product integrity during storage and transportation
• Cold chain management and temperature-controlled logistics
• Preventing contamination, counterfeit products, and theft
• Practical Exercise: Evaluating GDP compliance in a distribution facility

Module 5: Handling Non-Compliance and Regulatory Inspections

• Responding to audit findings and non-compliance issues
• Preparing for regulatory inspections and managing expectations
• Post-audit corrective actions and compliance reporting
• Case Study: Best practices for successful GDP audits