Scope
With the fast approaching deadline of the 9th of February 2019 to fully comply with the requirements of Falsified Medicines Directive(Directive 2011/62/EU) and the associated delegated act, this ‘hands on’workshop provides practical guidance on implementation within your own organisation.
It draws on expert advice to cover the key “Dos”, “Don’ts” and “Watchouts”, using a number of case study scenarios to illustrate, focusing on the technical challenges associated with implementation of the required systems and processes as well as how to monitor and control compliance from a quality point of view.
NOTE: This Workshop assumes an existing knowledge of the requirements of the Falsified Medicines Directive (FMD); those with limited knowledge of the Directive should consider attending our ‘Serialisation, FMD and Safety Features’ course as a foundation, prior to attending this workshop)
Suitability
This workshop is designed for individuals who have some knowledge of the FMD and Serialisation, and who wish to explore the practicalities of implementation.
In particular, personnel involved in Quality Assurance (QA), IT infrastructure, production, and wholesaling will gain a practical knowledge and understanding of how they can implement and apply the necessary IT infrastructure, controls and processes associated with the FMD within their own organisation.
Learning Outcomes
By the end of the course you will:
- Have a practical appreciation of the requirements of the EU’s FMD and delegated act
- Understand how these are expected to be applied across the whole pharmaceutical supply chain - manufacturing, import and export, wholesaling and dispensing of products to the end user.
- Have gained a practical understanding of how compliance will be governed within the EU, and what needs to be done in order to achieve compliance, relating this to your own company’s activities
- Appreciate the significant considerations that need to be taken into account when designing packaging, in order to comply with the requirements of the various countries
- Recognise how the impact on the design, creation and printing of packaging material (cartons, labels) as well as on IT solutions in packaging lines will need to be managed within your own company.
