Course Overview:
The pharmaceutical supply chain spans multiple countries and partners, creating challenges in traceability, quality oversight, and regulatory compliance. Global regulators have responded by strengthening requirements to protect product integrity. In the U.S., the Drug Supply Chain Security Act (DSCSA) introduced a national electronic track-and-trace system, while the EU continues to reinforce its Good Distribution Practice (GDP) standards. These developments emphasise that all personnel involved in procurement, distribution, logistics, and supplier oversight must understand their responsibilities and contribute to a strong quality system.
This training provides a practical overview of global supply chain expectations, key regulatory frameworks, and risk-based strategies that help organisations maintain compliant and reliable distribution practices.
Key Learning Areas
• Overview of DSCSA, EU GDP, and international supply chain regulations
• How agencies such as FDA and EU authorities enforce compliance
• Roles and responsibilities across the supply chain
• Integrating risk management into distribution and supplier oversight
• Strengthening the Quality System to support continuous improvement
Course Outline:
Day 1 Content
• Management responsibility in supply chain quality
• Current and emerging regulatory/customer requirements
• Cold-chain handling and storage controls
• Distribution process control and validation
• Documentation and record-keeping expectations
• Training and competency management
• Continuous improvement foundations
• Building an effective Supplier QA program (six-step approach)
Day 2 Content
• Recent regulatory trends in supplier management
• Essential SOPs and records for qualification and oversight
• Applying the six-step supplier quality planning model
• Identifying supplier risks and assigning risk ratings
• Developing Supplier Quality Agreements
• When reduced testing may be justified
• Managing suppliers operating within your own facilities
Participants
Designed for professionals involved in supply chain quality, procurement, supplier QA, logistics, warehouse operations, and distribution of pharmaceuticals, ingredients, and medical devices.