About the training
This Track and Trace Trainings course shall inform the pharmaceutical company XYZ about the International Serialisation requirements, about the requirements of the EU-Falsified Medicines Directive and about the technical and organisational implementation at the Pharmaceutical Manufacturer. This Track and Trace Trainings course workshop has been designed to provide you with the specialist knowledge and skills needed to achieve compliance. Also it will provide an understanding what the requirements are, which of these are already fulfilled and addressed at pharmaceutical company XYZ and which activities are still needed to reach compliance.
Decipher what are the requirements of the EU-falsified medicines directive regarding the unique identified and the anti-tampering device.
Learn about tested and proven techniques for serialisation application and tamper evident features in your packaging.
Be informed about the technical, organisational, quality and IT-related (onboarding) requirements for the pharmaceutical manufacturer and the corresponding implementation possibilities and technical solutions
Overview Global Serialization Requirements
EU Falsified Medicines Directive and Delegated Regulation – Overview and impact
Implementation of Serialization and Aggregation in production – Overview and impact
Implementation of Serialization – Quality Relevant Aspects
Case study: Implementation of Serialization – Technical challenges at the pharmaceutical manufacturer
Coding / Serialization / Artwork at the Manufacturer of Printed Packaging Materials
Case study: Technical and Organizational Implement-ation of Serialization at the Pharmaceutical Company
Print Quality of Barcodes and 2D Matrixcodes
DIN EN 16679 “Tamper Verification Features for MP Packaging” – Practical Implementation
Qualification & Validation of Serialization & Tamper Verification technologies in Pharma Packaging
Workshop / group work: Implementing Serialization and Tamper Evidence at Bosnalijek – Creation of a mind map and a project plan
Serialization, IT and Connectivity – Challenges and solutions
Future Developments - Outlook and implications