Pharmaceutical Packaging Systems - Part 1 - Development - Live Online Training
24/25 November 2026
Course No. 22468
Speakers
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
Book Part 1 (Pharmaceutical Packaging Systems - Development) and Part 2 (Pharmaceutical Packaging Systems - Quality Control) together and benefit from reduced fees! Please click here
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
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 EUR 1,490 APIC Members EUR 1,540 Non-ECA Members EUR 1,690 EU GMP Inspectorates EUR 845 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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