Heike Gottschalg, Boehringer Ingelheim, Germany
Dr Afshin Hosseiny, Chairman of the ECA GDP Association
Alfred Hunt, form. Irish Health Products Regulatory Authority (HPRA) and key member of the EMA drafting group for the revised EU-GDP Guidelines
Savvas Koulouridas, Fagron Hellas, Greece
Robert Müller, Boehringer Ingelheim, Germany
Rico Schulze, GMP/GDP Inspectorate, Germany
This education course provides practical guidance through workshops on how to perform gap analysis, prepare plans for implementing systems and procedures to bring your organisation in compliance with the GDP regulations.
The globalisation of the pharmaceutical supply chain has created new challenges for manufacture and supply of medicinal products in various markets, resulting in reduced control and increased security risk to the products.
The EU-GDP Guidelines have been extensively revised to take into account the changing nature of the globalised supply chain. The new requirements have been effective since 2013. These requirements highlight the need for an effective quality management system supported by risk assessment and appropriate controls.
This three day tutorial has been designed to bring you up-to-date with the current regulatory expectations and standards for Good Distribution Practice (GDP) and to provide you with tools and guidance to help you with identifying the gaps in your quality systems compared to the new requirements and planning and implementing the actions required.
Managers and executives from companies involved in the distribution and supply of pharmaceutical products.
The Inspector’s Point of View
GDP Inspection Findings and what to learn from them
- The new 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?
Workshops and interactive Sessions
Quality Management System (QMS)
- Findings and their ratings
- Examples from manufacturers, wholesalers, storage facilities and transport deviations
- 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
Premises & Equipment
- Key requirements for transportation of medicines
- How to develop and implement a GDP-compliant and cost effective transportation network.
- What is a must for medicinal products
- How to plan and implement facility improvement ensuring compliance with the current requirements
- 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
- Competency requirements for GDP personnel
- Overview of the role and responsibilities of the Responsible Person
- Necessary documentation
- Training matrix and managing continuous training
Contracts in the global Supply Chain
- What is an outsourced activity?
- How to set priorities to audit, approve and manage service providers
- How to develop and manage contracts and agreements
Lessons learned and Action Planning
Case Study for a successful Implementation
- 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
Summary and Take Away Message
- How we approached the new requirements
- Challenges and best practice
- Developing a take home action plan for the delegates