Dr Rainer Kahlich
GMP/GDP Inspector
Referierende
Alexander Gutbrod
Vetter
Dr Stephan Schwarze
StepS Consulting
Sergio Cuevas Luján
Teva
Ana Cláudia Pinho
BIAL – Portela & C.ª
Alexandra Wengerter
Merz
Christoph Merhold
Inductio
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 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 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 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
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
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
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)
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
Weitere Informationen
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Ms Sarah Schmidt, +49 62 21 84 44-16, s.schmidt@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 62 21 84 44-22, nicole.bach@concept-heidelberg.de
Recording from 04/05 November 2026
Duration of the recording: 9h 23m
Duration of the recording: 9h 23m
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Regular Fee*: | € 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"
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E-Mail: info@concept-heidelberg.de
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