The course is designed to provide an oversight to the attendees about the essentials of serialization and how Track & Trace can be implemented in companies with minimum interruption of daily routine manufacturing workload. It is the course’s goal to inform about the latest developments in serialization & authentication coming from the EU directive 62/2011/EC.

The course will support you in collecting, sorting and proper understanding of the relevant contained information related to the defined safety features, which are a unique identifier and tamper evident closures within the EU.

_{^{Who Should Attend}}

• Executive and operational managers of pharmaceutical companies, especially from packaging operations, as well as IT and engineering staff, responsible for the implementation or operation of the new systems are the target group of this event.

• Suppliers of packaging and authentication technology and pharmaceutical packaging companies

_^Outlines

• Consequences for the pharmaceutical industry
• What has to be implemented now
• Outlook – What else can be expected in this context?
• Print and verification of serialized barcodes
• Barcode specification and secure data transmission
• Artwork changes, verification and approval
• Print Quality of Bar and 2D Matrix Codes
• Testing of codes and Meaning of testing results
• Areas to be addressed: IT system – carton – processes
• Data management
• Packaging material management
• How to set up and start a packaging line with serialization
• Challenges in the implementation phase
• Equipment qualification/ process validation
• Quality related aspects e.g. adaptation of IPCs, training, SOPs etc.
• Case Studies