David Abraham, Quality Resource Solutions Associates, UK
Prabjeet Dulai, GDP & Quality Matters, UK
Heike Gottschalg, Boehringer Ingelheim, Germany
Isabelle Herre, GDP Inspectorate, Germany
Alfred Hunt, PharmaLex, Ireland
Savvas Koulouridas, Fagron BV, Netherlands
Robert Müller, Boehringer Ingelheim, Germany
This education course provides practical guidance through workshops and interactive sessions to bring and keep your organisation in compliance with the GDP regulations.
The globalisation of the pharmaceutical supply chain has created new challenges for the 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-todate 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 and planning and implementing the actions required.
GDP Compliance Managers and Responsible Persons from companies involved in the distribution and supply of medicinal products.
The Inspector’s Point of View
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?
GDP Inspection Findings and what to learn from them
- Findings and their ratings
- Examples from manufacturers, wholesalers, storage facilities and transport deviations
Workshops and Interactive Sessions
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
- Key requirements for transportation of medicines
- How to develop and implement a GDP-compliant and cost effective transportation network.
Premises & Equipment
- 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
- What is an outsourced activity?
- How to set priorities to audit, approve and manage Service Providers
- How to develop and manage contracts and agreements
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
Lessons learned and Action Planning
Case Study for a Successful Implementation Approach
- How we approached the new requirements
- Challenges and best practice
Summary and Take Away Message
- Developing a take home action plan for the delegates