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.
Background
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.
Target Group
All personnel involved in pharmaceutical storage, transportation, cold chain and distribution activities and the control of those activities.
Question and Answers Session
You will be able to send in GDP related questions before the conference. Additionally, questions can be posted on question cards during the conference.
Answers will be given by the expert speakers in a dedicated session and published in the members are of the GDP Association’s website (www.good-distribution-practice-group.org).
Programme
Performance beyond Compliance
Benchmarks with sense
When is a system or process robust?
Easily understandable key figures
Case studies
Brexit Implications
Import/ export issues
Drug shortage challenges
Falsification
Serialisation
Co-operation of the agencies
GDP Challenges in Africa
Background
Evolution of GDP over the years
Problems involved
Steps taken to improve
Customer Master Data
Definitions
Parties involved
Responsibilities and RP oversight
Managing Customer Master Data
Lifecycle Management
3 parallel Workshops: 1. Risk Management in GDP Warehousing
Challenges and possible solutions
Examples
2. When things go wrong – what can happen in the real World
Experiences made in examining problems in the supply chain – and what to learn from them.
3. How to deal with suspected and confirmed falsified Medicines
What is a suspected falsified medicine
How to identify falsified medicine in your workplace
How to approach the investigation of a suspected pack
What should the end user do with the pack – who should manage communication with the end users
You will be able to attend TWO of these workshops. Please choose the ones you like to attend when you register.
Case Studies: The Roche Quality Governance Model for Distribution to Direct Markets
Selection, implementation, operation and decommissioning of partners
Key Performance Indicators (KPIs)
Compliance score card
The Switch from Air-freight to Sea-Freight
Challenges and Benefits
Examples
From external to internal Solutions - Insourcing of Warehousing and Logistics
Implementation of own storage areas for minimum supply at the site
Container and transport vehicle purchasing (refrigerated, warm, hazardous)
2 parallel Workshops:
1. Master Data and Serialisation
Master Data for Serialisation
Alerts Handling
Exercises
2. Distribution of ATMPs
Challenges when dealing with ATMP
What information is needed to help service providers
Examples
You will be able to attend ONE of these workshops. Please choose the one you like to attend when you register.
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager" Learn more
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