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Heike Gottschalg, Boehringer Ingelheim, Germany
Ursula Greene, McGee Pharma International, Ireland
Dr Afshin Hosseiny, Tabriz Consulting, U.K.
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 September 2013. These requirements highlight the need for an effective quality management system supported by risk assessment and appropriate controls. Do you think you are compliant with the new requirements?
This two day tutorial has been designed to bring you up-to-date with the current regulatory thinking 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 Inspectors 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
A step-wise Approach:
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 sGDP-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
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
GDP – how we got there
How we approached the new requirements
Challenges and best practice
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
Summary and Take Away Message
Developing a take home action plan for the delegates