Track & Trace Training Course - FMD Mandatory in Four Months!
Im Auftrag der ECA Academy

Track & Trace Training Course - FMD Mandatory in Four Months! Im Auftrag der ECA  Academy

Berlin, Germany

Seminar Nr. 16664


Kosten

Non-ECA Members: EUR 1690,--
ECA Members: EUR 1490,--
EU GMP Inspectorates: EUR 845,--
APIC Members (does not include ECA membership): EUR 1590,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Thomas Brückner, BPI (invited)

Maren Göpfert, Boehringer Ingelheim Pharma

Horst Kastrup, Senior Expert, Germany

Dieter Mößner, Edelmann GmbH

Dr Stephan Schwarze, Bayer AG

Wilfried Weigelt, REA Elektronik GmbH

Zielsetzung

It is the course’s goal to inform about the latest developments in serialisation & 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.

Hintergrund

Directive 2011/62/EC also known as “EU Falsified Medicine Directive” came into force already in 2011. Not before October 2015, the final draft of the corresponding Delegated Regulation was made known to the public following the adoption by the EU Commission.

Finally, by 9th February 2016 the “Commission Delegated Regulation (EU) 2016/161” “supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use” was published in the Official Journal of the European Union. As consequence, the rules will be applied from 9th of February 2019 onwards except for some member states with an existing Verification System.

Furthermore, recognizing that some of the defined rules need further interpretation frequently updated Question and Answer documents have been published (e.g. Version 10 on July 6, 2018) on the Commission’s website to provide guidance.

In addition, the EMA had updated on 29 June 2017 their Implementation Plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use confirming the implementation date of 9th of February 2019; CMDh has issued a similar document for nationally authorised products.

Like many of such regulation 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. The German Initiative “securPharm” is the only system in the EU which is in compliance with the published delegated regulation that has already been implemented successfully. Some other national systems are announced to follow in first half of 2018.
A report about the current status is part of the training course. Beyond this an insight in the current global landscape of serialisation and coding requirements and system is provided as well.

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. The German Initiative “securPharm” is the only system in the EU which is in compliance with the published delegated regulation that has already been implemented successfully. A report about the current status is part of the training course. Beyond this an insight in the current global landscape of serialisation and coding requirements and system is provided as well.
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 serialisation mean 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 serialisation system?
  • What are the relevant aspects to be addressed from a quality point of view?

Zielgruppe

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.

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:
FMD ready in 4 months: What is still to be done?
Alternative approaches / Backup plan: What should be done to secure the supply chain
What is the perspective after 09 February 2019? / What to come next?

Programm

Delegated Act for the Safety Features – Impact Assessment for the Pharmaceutical Industry

  • Which are the most relevant aspects?
  • Consequences for the Pharmaceutical Industry – What has to be implemented until February 2019 ?
  • Outlook – What else can be expected in this context?
Technical and Organisational Serialisation Possibilities for the Pharmaceutical Manufacturer
  • Serialisation 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, securPharm/EU
  • End of line serialisation at the pharmaceutical manufacturer
  • Serialisation at the contract manufacturer
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
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
Serialisation and Coding Requirements Worldwide
  • Global overview and different systems in Europe, USA, Russia, South Korea, China, Taiwan, India, Middle East, Egypt, Turkey, Latin America etc.
  • Country-specific rules in the EC Member States (potential inclusion of reimbursable OTCs, re-serialisation and tamper evident closure, choice of product identifier etc.)
  • Collection of country specific requirements/ Worldwide project management
  • Technical specifications for the manufacturing sites
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

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

Workshop I
Implementation of 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 3 Workshops.

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