Pharmaceutical Packaging Systems - Part 1: Development & Part 2: Quality Control - Live Online Training
With Case Study on Reduced Testing / Reduced Sampling!
24-26 November 2026
Course No. 22469
Speakers
Dr Gerald Kindermann
GxP Consulting
Dieter Mößner
Packaging Expert
Peter Huonker
Lonza
Torsten Kneuss
Bayer
Dr Katrin Buss (invited)
Bundesinstitut für Arzneimittel und Medizinprodukte
Katharina Golly
Novartis
Dr Deolinda Izumida Martins
West Pharmaceutical Services
Sergio Cuevas Luján
Teva
Vincent Jeanguyot
Novartis
Dr Haakon Wiedemann
Schott AG
Highlights • Regulatory Requirements & Compendial Standards • Sterile Packaging Material & Container Closure Integrity (CCI) • Packaging and the Common Technical Document (CTD)
Target Group
These GMP Education Courses are designed for employees working in pharmaceutical research and development, regulatory affairs, quality control, incoming goods control of packaging materials, and quality assurance departments. They are also directed at employees of suppliers of primary and secondary packaging materials for the pharmaceutical Industry.
Objectives
The development of pharmaceutical packaging systems is an increasingly complex topic, which is reflected in the most recent requirements for combination products and sterile packaging materials (Annex 1 of the EU GMP Guide). To cover all relevant aspects a thorough target product profile needs to be set up. Not only regulatory requirements drive container closure system development, but also current challenges such as package integrity, glass delamination and particles on ready-to-sterilize (RTS) and ready-to-use (RTU) components.
The focus of these 2 GMP Education Courses is on the development and routine control of pharmaceutical packaging Systems.
In Course 1 participants will learn how to develop pharmaceutical packaging materials systematically, and how to translate the requirements of the Common Technical Document (CTD) to regulatory documents for packaging materials. Topics to be addressed include compendial standards, container closure integrity, and combination products.
Course 2 will focus on the testing of a variety of different packaging materials, as carried out in every incoming-goods laboratory in quality control. This includes the setting of sound and scientific specifications and Acceptable Quality Levels (AQLs), the control of dimensions, and the control of primary and secondary packaging materials.
Programme
Part 1: Pharmaceutical Packaging Systems - Development
Regulatory Framework applicable to Pharmaceutical Packaging Materials
Code of Federal Regulations (CFR)
US Guidance for Industry: Container Closure Systems
Packaging Related Topics of the Common Technical Document (CTD)
CTD structure (packaging related)
Quality of components and materials
Declaration of compliance
Information to be provided in the dossier
Specific Aspects for Glass Materials
Why glass for pharmaceutical packaging?
The science behind glass
A glimpse into glass production
Outlook: Is there a chance for a sustainable glass production?
Q&A Session 1
Specific Aspects for Plastic Materials Vials and PFS made of Polymer
Extractable Elements
Sterilization Aspects
Critical Parameters
How to provide data to Regulators
Examples
Specific Aspects for Elastomeric Materials
Material background
Compendial compliance
Formulations and extractable elements
Sterilization
Critical Parameters
Extractables & Leachables
E&L Regulatory Landscape
Potential sources of Leachables
E&L Best practices
Case study(-ies)
Q&A Session 2
Regulatory Expectations on Drug / Device Combinations
Medicinal products vs. medical devices
Legal requirements and scientific guidelines
Medicinal products with medical device part
Development of Drug/Device Combination Products
Regulatory Background
Design Control
Usability
Risk management
Container Closure Integrity (CCI)
Definition (Leakage)
Test methods
USP <1207>
Challenges & Solutions
Q&A Session 3
Part 2: Pharmaceutical Packaging Systems - Quality Control
Defect Evaluation Lists
Principles for the Defect Evaluation Lists (DELs)
Application of AQLs (Acceptable Quality Levels)
Examples for Containers made of moulded and tubular glass
Control of Printed Packaging Materials
Defect Evaluation Lists for Secondary Packaging Materials
Printing, Coding & Artwork
Serialization & Tamper Evidence
Defect classes and (100%) test procedures (Examples)
Technical Specifications
Scope & content
Concept (proposal)
Defect classes and selected test procedures (Example)
Shelf-life of Packaging Components
Why is a defined shelf-life required?
How to define the shelf-life for packaging components?
Re-Testing of packaging components
Q&A Session 1
Qualification of Analytical Instruments used for Packaging Control
Important points for qualification (IQ/OQ/PQ)
Software validation
Examples (e.g. tensile testing)
Control of Primary Packaging Materials - Examples for Pouches and Blisters
Overview of the development / production of pouches / blisters
Control of process parameters / products during production (IPC)
Control of final products
Supplier Management
Applicable GMP standards for packaging suppliers
Selection of suppliers
Technical agreements, supplier qualification and audits
Continuous supplier evaluation
Q&A Session 2
Risk Based Inspections of Packaging Materials
How to set up a control system for packaging materials
Practical application of FMEA
What, why, and how to test
Strategies for reduced testing
Case Study on Reduced Testing / Reduced Sampling
Inspection Procedures for Primary and Secondary Packaging Materials
Q&A Session 3
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) If you book both courses " Part I: Pharmaceutical Packaging Systems - Development " AND the course " Part II: Pharmaceutical Packaging Systems - Quality Control" simultaneously, the fee for each conference reduces as follows:
ECA Members EUR 1,290 APIC Members EUR 1,340 Non-ECA Members EUR 1,390 EU GMP Inspectorates EUR 695 The conference fee is payable in advance after receipt of invoice.
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.
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