Dr Rainer Kahlich
GMP/GDP Inspector
Referent:innen
Alexander Gutbrod
Vetter
Dr Stephan Schwarze
StepS Consulting
Sergio Cuevas Luján
Teva
Daniel Guirao Navarro
Reig Jofre
Ana Cláudia Pinho
BIAL – Portela & C.ª
Alexandra Wengerter
Merz
Zielgruppe
Staff from QA and production engaged in packaging operations is the target group of this course as well as suppliers for equipment and packaging material used for packaging of medicinal products.
Zielsetzung
This GMP Live Online Training Course aims at easily explaining the GMP requirements for packaging of medicinal products.
This includes requirements for premises and equipment but also for QA operations like documentation, line clearance, validation etc.
This includes requirements for premises and equipment but also for QA operations like documentation, line clearance, validation etc.
Background
Packaging of medicinal products, blistering as well as cartoning for example, plays a crucial role in the quality and safety of a medicine. Deficiencies of primary packaging may alter the efficacy or stability of a product; failures in secondary packaging may do harm to patients even worse when products or the folding boxes are mixed up. Therefore, packaging is defined as (the last) pharmaceutical manufacturing step and one of the most critical ones. It is not surprising that the biggest part of recalls is caused by failures during packaging. On the other hand, despite the high criticality of the packaging process, the packaging plants are required to cut the costs and raise their efficiency.
Another challenge for the packaging units is the EU Directive, requiring safety features and authentication measures in order to raise the hurdle for drug counterfeiters. Packaging lines have to be equipped with systems for printing and reading two dimensional codes (2D-Codes) and these systems have to be linked to the materials management system.
There are numerous requirements which have to be fulfilled in the packaging plant. During this GMP Live Online Training we will focus on:
Another challenge for the packaging units is the EU Directive, requiring safety features and authentication measures in order to raise the hurdle for drug counterfeiters. Packaging lines have to be equipped with systems for printing and reading two dimensional codes (2D-Codes) and these systems have to be linked to the materials management system.
There are numerous requirements which have to be fulfilled in the packaging plant. During this GMP Live Online Training we will focus on:
- Compliance & QA requirements
- QA Systems
- Hygiene and Cleaning
- Qualification / Validation
- Technological aspects
- Facility and Zone Concepts
- Design of packaging equipment
- Packaging materials
- Handling, storage and mix-ups
- Suppliers
- Special topics:
- Serialisation & Authentication
- Electronic Product Information (ePI)
Programm
Programme Day 1
General GMP requirements for Packaging Operations / Key Compliance Challenges
- GMP-requirements in the packaging unit
- Important Guidelines and Standards
- QA-Systems relevant for packaging operations
- Typical labelling issues
- Inspection findings, quality defects and what to learn from them
Packaging Facilities & Premises / GMP Aspects for Packaging Lines
- Zone Concepts for primary and secondary packaging
- Air-Lock concepts
- Hygiene
- HVAC-System
- Cross Contamination – how to avoid it
Q&A Session 1
Qualification and Validation
- Risk-Based Approach incl. Definition of Critical Parameters
- Bracketing Options
- Documentation and Evidence
- Common Weak Points in Packaging Operations
Lean Processes & Continuous Improvement
- Continuous evaluation of the accuracy of SOPs
- Simplification of SOPs
- Opportunities for improvement
- Agile and effective mechanism to identify changes and execute the corresponding CCPs on time
Implementation of Pharmaceutical Processes in Secondary Packaging
- Introduction
- Fundamentals of Secondary Packaging
- Process Implementation – Step by Step
- Material Definition
- Process Design
- Qualification & Validation
- Commercial Manufacturing
- Specific Challenges
- Wrap-Up
Q&A Session 2
Programme Day 2
The Application of GxP in Packaging Supply
- Understanding GxP Principles in Packaging
- Introduction to Defect Evaluation
- Documentation and Traceability
Reducing Risk through Supplier Auditing
- Importance of Supplier Auditing in Risk Reduction
- Risk-Based Supplier Segmentation
- Common Findings and Corrective Actions
- Building Long-Term Partnerships Through Compliance
How to Minimize Risk in Sterile Packaging
- Design Aspects – What need to be considered?
- How to handle packaging materials for aseptic processing
- Media Fill
- Container Closure Integrity (CCI)
Q&A Session 3
Serialization and Aggregation – How It Was Implemented, What Worked, and What Didn’t
- Implementation challenges
- Current Status
- Expectations & Global Challenges
- Handling of Failures / Deviations / Complaints
Patient Information Leaflets (PIL) Footprint – How to Move to ePI and Its Advantages
- From Static to Smart
- Quantifying the Impact
- Smart Tech, Smarter Communication
- Implementation & Impact
Q&A Session 4
Weitere Informationen
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.
Fees (per delegate plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice and includes conference documentation as pdf files.VAT is reclaimable.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Dr Andrea Kühn-Hebecker (Operations Director), +49(0)62 21/84 44 35, kuehn@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach (Organisation Manager), +49(0)62 21/84 44 22, nicole.bach@concept-heidelberg.de
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.
Fees (per delegate plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice and includes conference documentation as pdf files.VAT is reclaimable.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Dr Andrea Kühn-Hebecker (Operations Director), +49(0)62 21/84 44 35, kuehn@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach (Organisation Manager), +49(0)62 21/84 44 22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 04 November 2026, 09.00 - 17.00 h
Thu, 05 November 2026, 09.00 - 16.00 h
Thu, 05 November 2026, 09.00 - 16.00 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Packaging Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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