On request
This training will be given on request only. This means that a date will be scheduled in case of >5 enrollments.
Target audience
- Employees directly or indirectly involved in the storage and or transportation of medicinal products.
- If you work as a Responsible Person or intend to start doing so, we recommend you to participate in the training GDP - Responsible Person.
Approach
GDP - Good Distribution Practice is an interactive training at mbo/hbo level. During this training we pay a lot of attention to the risks for product quality in the distribution of medicines. We also discuss the legal framework, regulatory requirements and recent developments. We teach participants how to set up a quality management system and its main components. We also discuss the importance of documentation, points for attention in case of returns, recalls and the principles of the Rapid Alert System, risk management, validation and monitoring.
Program
Introduction of GDP-regulations
- Laws and regulations governing medicinal products
- Licensing system
- EU guideline 2013/C 343/01
- Recent developments
GDP Quality System
- Key elements including Self-inspections, deviations, CAPA, Change control
- Complaints and recall, risk management
Temperature controle during storage and transport
- Cold Chain, storage temperature control
- Transport temperature control, validation and monitoring of temperature conditions
Warehouses, receipt and delivery of medicinal products
- Warehouse layout, receiving, storage, delivery, return goods
Qualification of customers and suppliers
- Qualification system, process and importance of customer qualification
Outsourcing activities
- Responsibilities, agreements, outsourcing of transportation
Falsified medicines
- EU-directive 2011/62/EU ‘Falsified Medicines Directive’ (FMD)
