Track & Trace Training Course - The implementation phase after 9th February 2019!

Track & Trace Training Course - The implementation phase after 9th February 2019!

Prague, Czech Republic

Course No 17493


This conference already took place. To get a list with courses and conferences in a specific subject area according to your professional demands, please visit GMP Training Courses and Conferences by topic.

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Thomas Brückner, BPI  Berlin
Maren Göpfert, Boehringer Ingelheim Pharma
Dieter Mößner, Edelmann GmbH
Dr Stephan Schwarze, Bayer AG
Wilfried Weigelt, REA Elektronik GmbH


It is the course’s goal to inform about the latest developments in serialization & authentication coming from the EU directive 2011/62/EC and the corresponding Delegated Regulation as published in the Official Journal of the European Union. Best practice examples will demonstrate how the new European requirements on verification of the authenticity of each single medicinal product can be put into practice.


Since 9th of February 2019 the Commission Delegated Regulation applies. Since then detailed rules for safety features on the packaging of medicinal products for human use are in place and need to be followed.

Frequently updated Question and Answer documents have been published to provide guidance.

Like many of such regulationS it is burdensome to read through these documents and sometimes it is also challenging to capture the relevant content. Key for a successful implementation of the applicable regulation is the understanding of what is really in there for you and what is actually relevant.
The training 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.

Practical examples will be presented and further discussed in corresponding workshops during this training course dealing with questions like:
  • What is the impact of the delegated regulations for the safety features in the EU on the pharmaceutical industry?
  • What does coding and serialization means for manufactures of printed packaging material?
  • How is the code quality defined and how to test the appropriate code quality?
  • Which kind of technical challenges have to be considered during the implementation of a serialization system?
  • What are the relevant aspects to be addressed from a quality point of view?
  • What are the challenges for manufactures since 9th February 2019?

Target Group

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 are also welcome.


Some of the most important topics of this course will be further discussed in workshops or in interactive discussions.

Workshop I
Compliance with the requirements for Serialization – Quality Relevant Aspects

In this workshop participants will discuss the following topics:
  • Serialization and Packaging Process – Which are the determining factors to maintain quality in course of packaging processes?
  • Serialization and Quality – Which are the most important SOPs to be implemented immediately?
  • Serialization and Complaints – How should a complaint handling concept look like to address serialization aspects appropriately?

Workshop II
Print Quality of Bar Codes and 2D Matrixcodes

The aim of this workshop is to evaluate how to measure the print quality:
  • What is the influence of  properties of different print technologies to the code print quality?
  • How to evaluate the ISO Data Structures (GS1, PPN, HIBC) used in Bar and 2D Codes?
Workshop III
Handling of Alarms

Participants will be able to attend all  these three Workshops.


Delegated Act for the Safety Features – Impact Assessment for the Pharmaceutical Industry
  • Which are the most relevant aspects?
  • Consequences for the Pharmaceutical Industry – What are the experiences so far?
  • Outlook – What else can be expected in this context? 
Technical and Organisational Serialization Possibilities for the Pharmaceutical Manufacturer
  • Serialization at the manufacturer of printed packaging materials
  • Artwork changes, verification and approval
  • Barcode specification and secure data transmission
  • Inprocess controls and quality assurance
  • Case Studies China, Korea, USA, EU, Russia
  • End of line serialization at the pharmaceutical manufacturer
  • Serialization at the contract manufacturer
  • Experiences in implementation of the Delegated Act for Safety Features since 9th February
Print Quality of Bar and 2D Matrix Codes
  • What does the EC Delegated act contain regarding
  • Bar- and 2D Codes
  • ISO Symbology and print quality standards (Bar- and 2D-Codes)
  • What is GS1 Data Matrix, GTIN, NTIN, PPN?
  • Testing of codes – why measure a code and not just scan?
  • Meaning of measuring results
  • China Code
  • Experiences in implementation of the Delegated Act for Safety Features since 9th February
Case Study: Implementation of Serialization and Aggregation – Challenges in Packaging and Supply Chain
  • Areas to be addressed: IT system – carton – processes
  • Challenges in the implementation phase
  • Equipment qualification/ process validation
  • Packaging material management
  • Impact on the Supply Chain
Case Study: Implementation of Serialization – Quality Relevant Aspects
  • Data Handling – What is relevant, e.g. related to
  • master data, CMOs, packaging, post release?
  • In-Process-Control steps – Adaption necessary?
  • Transparency and visibility of processes/behaviour – Any consequences?
FMD and Delegated Regulation on Safety Features -  Implementation in Europe and in the securPharm System
  • Current status of the implementation in Europe
  • State and technical development of the “securPharm World” – news and background information
  • Next steps and challenges in 2018 and beyond
DIN EN 16679 and ISO 21976 “Tamper Verification Features for Medicinal Product Packaging” – Practical Implementation
  • Which safety features does the EU falsified medicines directive require?
  • Which tamper verification guidelines / “standards” are available?
  • Structure and contents of the European standard EN 16679 / technical characteristics of tamper verification features
  • ISO 21976 “Tamper Verification Features for Medicinal Product Packaging”
  • Conclusions / Recommendations for the Practical Implementation
  • Qualification and Validation of tamper verification Features
Discussion Forum
In addition, there will be a Discussion Forum at the end of day one where all delegates will have the opportunity to ask specific questions to benefit from the speakers’ experiences in this field. Topics that could be addressed are:
  • Experiences with the FMD so far
  • Alternative approaches / Backup plan: What should be done to secure the supply chain

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