Welcome and Introduction
The GDP Guidelines: What is it all about?
- Background to development and revision of the new
- EU GDP Guidelines
- Well-known or new: A summary of the most important changes
- A look into the crystal ball: What is the impact on industry and other stakeholders?
Quality Management System (QMS)
- What is a QMS and why do we need it?
- What does an effective QMS look like?
- How to develop and implement an effective QMS
- Qualification of suppliers and customers
- Receipt, storage and return of medicinal products
- Deviation and Complaint Management in a wholesaler facility
- How to conduct a gap analysis, develop plans and implement the new requirements
Questions & Answers Session I
GDP Inspection Findings and what to learn from them
- Findings and their ratings
- Examples from manufacturers, wholesalers, storage facilities and transport deviations
- Competency requirements for GDP personnel
- Overview of the role and responsibilities of the
- Responsible Person
- Necessary documentation
- Training matrix and managing continuous training
Questions & Answers Session II
Premises & Equipment
- What is a must for medicinal products
- How to plan and implement facility improvement ensuring compliance with the current requirements
- Key requirements for transportation of medicines
- How to develop and implement a GDP-compliant and cost effective transportation network.
Contracts in the Global Supply Chain
- International laws and systems – how they work and fit together
- Jurisdictions and conflict of law provisions
- Contract law, Technical/ Quality Agreement, Supply Agreement
- 3PL Providers: two bilateral agreements or one tripartite agreement?
- When things go wrong
Questions & Answers Session III
- What is an outsourced activity?
- How to set priorities to audit, approve and manage service providers
- How to develop and manage contracts and agreements
Case Study for a successful Implementation Approach
- How we approached the new requirements
- Challenges and best practice
Short Summary and Take Away Message
- Developing a take home action plan for the delegates
Questions & Answers Session IV