Chapter 1: Understanding GDP and Regulatory Framework
- Welcome and Introduction
- Overview of GDP for Medical Devices
- Key principles of GDP
- Understanding the Medical Device Regulation (MDR) requirements for distribution
- Identifying and managing risks in distribution
- Q&A Session
Chapter 2: Implementation, Quality Management, and Best Practices
- Implementing GDP in the Supply Chain
- Role of Quality Management Systems in GDP
- Documentation and record-keeping
- Audit and self-inspection
- Best practices in handling recalls and non-conformance
- Q&A Session
- Feedback and closing remarks
Quality assurance professionals responsible for ensuring that medical devices meet the necessary quality and safety standards throughout the distribution process.
Professionals who manage regulatory compliance related to the distribution of medical devices within the EU and need to stay updated on current regulations and practices.
Professionals overseeing the logistics and supply chain operations for medical devices, including storage, transportation, and handling.
Warehouse and distribution center managers in charge of storage facilities for medical devices.
Professionals involved in monitoring the safety of medical devices in the post-market phase, who need to understand the distribution process’s impact on device safety and performance.
Individuals studying or researching in fields related to medical device distribution, regulatory affairs, or healthcare management.
Training will be in the form of an interactive workshop. It will include presentations, discussions, and Q&A.