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The aim of this conference is to inform about recent experiences made in the implementation of the EU-GDP Guidelines.
Challenges and possible solutions will be discussed and examples will demonstrate how the requirements can be put into practice.
It is of key importance that medicinal products are not only made to a high quality in accordance with Good Manufacturing Practice (GMP), but that the quality and integrity of these products are maintained through the entire supply chain to the patient. This is where Good Distribution Practice (GDP) comes into play.
In the last few years the world of GDP has changed in scope and complexity and continues to evolve to meet new challenges with the continued aim of safeguarding public health. The Falsified Medicines Directive (2011/62/EU) was transposed into the laws and regulations of the EU Member States alongside the introduction of revised EU guidelines on Good Distribution Practice. Many other countries followed adopting these Guidelines or implementing very similar approaches.
All personnel involved in pharmaceutical storage, transportation, cold chain and distribution activities and the control of those activities.
Every participant will get a free copy of the GDP Guidance on interpretation and implementation, a joint publication of the ECA Foundation and the
Pharmaceutical Quality Group of the Chartered Quality Institute.
Key Note: The X-Factor
Human Behaviours and Errors and what the Responsible Person needs to know about these
Import/Export Activities and their Link to GDP
Import/export activities and their link to GDP (and what an inspector would expect
regarding the GDP quality oversight)
Data Integrity in the Supply Chain
The flow of data and how to control it
Data Governance- what’s it all about?
The paper – IT interface
How to reduce risks
How to handle data and document from partners in the supply chain
Lean GDP – a risk-based Approach for Compliance
How lean is lean?
Efficiency without compromising Quality
How do we deal with guidelines that allow alternative approaches?
Risk management and other tools
Qualification in Transportation of Medicinal Products
Main drivers for qualifications in transportation of medicinal products
From API to medicinal samples for HCPs
Qualification subject and applicable methodology for each transport mode
In-house and outsourced activities interactions with highlights on 3PL and 4PL roles
Three parallel Workshops:
1) Supply Chain Mapping and Qualification