Good Distribution Practice Training

This two day training course aims to offer participants a comprehensive understanding of Good Distribution Practice (GDP) and Temperature Controlled Logistics (TCL) in relation to the EU guidelines and the requirementsof the Irish Regulatory Authority (Irish Medicines Board – IMB).
After this training session you will:

• Understand the regulatory requirements and constraints facing manufacturers and distributors in the management of the supply chain from sourcing to final distribution including the use of supply chain partners and the standards required of them
• Become familiar with E 94C 63/03 guidelines and the Irish Medicines Board (IMB) guidelines on GDP and the expectations of the regulator.
• Identify the controls necessary to ensure compliance with GDP along the supply chain including all facilities used.
• Latest expectations on Temperature Controlled Logistics, including an introduction to review of temperature mapping, temperature management, route qualifications managing general and and cold chain products.
  

This course offers a practical explanation of the current guidelines for those who are active in the field of setting up and/or implementing GDP, as well as the management of quality systems and the supply chain for Pharmaceutical and Medical Device Products. The training workshop is highly interactive aimed at individuals who wish to increase their knowledge and understanding of the current requirements of GDP.

Who is it for?

• Manufacturing Quality Personnel overseeing Compliance in Warehousing, Distribution and Transportation Activities
• Warehousing & Distribution Supervisory and Management Staff
• Quality Assurance Personnel engaged in Auditing & Inspecting Logistic Service Providers.
• Corporate Quality & Logistics Executives with input into overseeing supply chain quality compliance.
• Pharmaceutical Manufacturers
• Medical Device / Diagnostic Manufacturers
• Supply Chain Service Providers
• Distribution Companies

Content:

• Quality Systems
• Standard Operating Systems
• Records
• Premises & Equipment
• Receipt
• Storage
• Deliveries to Customers
• Distribution
• Transportation
• Temperature Management
• Returns Management
• Handling Returns
• Authorisation
• Records
• Release to Saleable Stock
• Authorised Disposal
  
• Recalls Management
• Traceability and Importance
• Supply Chain Visibility
• Counterfeit Medical Products
• Security & Transit Requirements

Basic Rules of Temperature Controlled Logistics

• Terminology
• Temperature Mapping
• Temperature Monitoring
• Route Qualification
• Excursions & How these should be managed
• Documentation
• Validation
• Equipment
• Calibration
• Designated Responsibility
• Transportation Modes
• Audits / Self Inspections
• Quality Systems

Duration:

Two Day Training 9.30 am – 5.00 pm.