The EU-GDP Guidelines
- The counterfeit directive and the introduction of the EU GDP Guidelines
- GDP requirements for the pharmaceutical supply chain
- Regulatory expectations for implementation
Roles and Responsibilities of the Responsible Person
- Qualifications requirements for RPs
- Duties and delegation
- How to discharge your duties
Experiences from GMDP Inspections
- Inspections of the competent authorities
- Typical GDP inspection findings
Controlled Temperature Distribution
- How to manage cold chain products
- How to manage 15 – 25 °C requirements
- Air freight, sea freight, road transport and the last mile
GDP Audits
- How to plan the Audit
- Approach to GDP Audits
- Reporting deficiencies
- Examples of recent audit findings
Management of Export and Import
- Annex 21: Importation of medicinal products
- What does batch release mean?
- Export and import to and from UK
Validation of Computerized Systems under GDP Regulation
- Validation requirements – regulatory overview
- GAMP oriented validation approach of GDP critical systems
Case Study: Validation of a new Warehouse and Material Management System
Workshop: Deviation Management
During this workshop participants will learn and discuss how to ensure that the deviation System is being correctly used and implemented.
Roles and Responsibilities of an RP and a QP
- Responsible Person vs. Qualified Person
- GDP vs. GMP
- Product finishing activities
- Product diversions
- Handling of returned and damaged goods
- Complaint Handling
Security in the Supply Chain – what is expected and how Industry is approaching it
- FMD and its role in supply security
- How can track and trace improve supply chain security
- What is available and how to implement