Avoiding non-Compliance in Packaging Operations - Live Online
How to avoid Mix-Ups, Contamination and labelling issues
4/5 November 2026
Course No. 20643
Speakers
Dr Rainer Kahlich
GMP/GDP Inspector
Alexander Gutbrod
Vetter
Dr Stephan Schwarze
StepS Consulting
Sergio Cuevas Luján
Boehringer Ingelheim
Daniel Guirao Navarro
Reig Jofre
Ana Cláudia Pinho
BIAL – Portela & C.ª
Alexandra Wengerter
Merz
Target Group
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.
Objectives
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.
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:
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)
Programme
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
Further Information
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
Date & Time
Wed, 04 November 2026, 09.00 - 17.00 h Thu, 05 November 2026, 09.00 - 16.00 h
Testimonials
