Serialization/Aggregation - Live Online Training

23/24 October 2024

Course No. 21429

header-image

Speakers

Dr Ulrich Kissel

Dr Ulrich Kissel

European QP Association (EQPA), KisselPharmaConsulting

Emil Schwan

Emil Schwan

Swedish Medical Products Agency

Wilfried Weigelt

Wilfried Weigelt

REA Elektronik

Laura Ribeiro

Laura Ribeiro

OCP

Dieter Mößner

Dieter Mößner

Verpackungsexperte

Note: All times mentioned are CEST.

Objectives

It is the course’s goal to inform about the latest developments regarding the compliance with the Falsified Medicines Directive 2011/62/EU and its Delegated Regulation EU 2016/161. Best practice examples will demonstrate how the requirements on verification of the authenticity of each single medicinal product can be fulfilled and false alerts can be managed efficiently. In addition, global aspects, like aggregation and the different types of coding will be covered.

Background

Since 9th of February 2019 the Commission Delegated Regulation applies. With it the 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 in addition to provide guidance. Moreover three Aide Memoires have been published for:
  • GMP INSPECTIONS OF MANUFACTURERS,
  • GDP INSPECTIONS OF WHOLESALERS,
  • INSPECTIONS OF PHARMACIES
COMPLIANCE WITH COMMISSION DELEGATED REGULATION (EU) 2016/161 FOR SAFETY FEATURES.
 
More than four years in the operational phase of the EU Verification System a significant number of manufacturers and supply chain actors have still not connected to the system.

In addition, the Industry is still fighting with false alerts and most of the member states are still in stabilization phases. Scans undertaken by supply chain actors often lead to false alerts being generated due to various reasons, such as:
  • Missing data upload into the European Hub,
  • Incorrect data upload,
  • Incorrect scanner configuration of end-users,
  • Pharmacy / hospital software systems not updated,
  • Procedural reasons,
  • System not used properly.
This live online training course will support you in collecting, sorting and proper understanding of the relevant requirements related to the defined safety features.
Practical examples will be presented and further discussed in corresponding Q&A sessions, dealing with questions like:
  • What are the challenges of the EU delegated regulation for  safety features  the supply chain actors are currently facing?
  • What are the weak points of the current End-to-End verification System?
  • Will aggregation soon be required in the EU?
  • What are the requirements regarding serialization / aggregation on a global level?
  • What are the requirements for Medical Devices?
  • How could a best practice process of suspected falsified medicines handling may look like?
  • Do we need a new alert management system or will we use established quality systems?
  • What to do if a real falsification is the most likely conclusion?

Target Group

Executive and operational managers of all actors of the supply chain (e.g. manufacturers, pharmacies, hospitals, wholesalers, dispensing doctors), as well as IT and engineering staff, responsible for the implementation or operation of the systems are the target group of this event.

The topics provided are also of interest for QA personnel dealing with alerts and complaints, QPs, suppliers of packaging (and authentication technology) and devices, and GMP/GDP Inspectors.

Technical Requirements

We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.

Programme

Serialization/Aggregation - Live Online Training

Seminar Programme as PDF

Programme Day 1
 
EU FMD and Associated Regulations
  • Overview and context
  • Requirements as defined in the Delegated Regulation
  • What can be expected next?
Regulators` View
  • GMP/GDP Regulatory expectations
  • Approval of artwork and InformationƒExamples for “Artwork Errors” including not applying correct serialisation or uploading incorrectly
Q&A Session 1
 
Handling of Alerts: View of an NMVO
  • Successful handling of alerts
  • ƒHow the challenges regarding alerts are addressed
  • How the stakeholders were brought on board
  • ƒHow the number of alerts was brought under control
View of a Wholesaler
  • How to deal with suspected and confirmed falsified medicines
  • Who should manage communication with the end users
  • Current issues
View of a QP
  • Do we need a new alert management system or will we use established quality systems?
  • Is a modification of deviation management required?
  • Safety features and Serialization: How do they impact our complaint management systems?
  • What to do if real falsification is the most likely conclusion?
  • Impact of safety features and serialization on certification
  • Data, data management and QPs
  • The QP´s wish list on serialization
Q&A Session 2
 
 
Programme Day 2
 
Aggregation - Practical Examples:
Aggregation with Folding boxes, Bundles, Outer Packaging, Pallets
  • Selected regional requirements for Aggregation (e.g. Turkey, US, …)
  • Practical examples of Track & Trace Systems (from Folding Boxes to Pallets)
Coding: Practical Examples
  • Requirements & Practical Examples
  • Printing, Coding & Control
  • Scanning
View of a Pharma Company
  • Implementation challenges (EU)
  • Current Status (EU)
  • Expectations & Global Challenges: Canada, Russia, Ecuador
Serialization: Medical Devices
  • Overview
  • ƒRequirements of the Medical Device Regulation (MDR)
  • UDI (Unique Device Identification) and Eudamed Database
  • Coding techniques for UDI
  • Testing and verification of data
Q&A Session 3

stop

This course is part of the GMP Certification Programme "ECA Certified Packaging Manager" Learn more

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023