Referent:innen

Katharina Golly

Katharina Golly

Novartis

Jean-François Decoster

Jean-François Decoster

UCB Pharma

Dr. Katrin Buss (invited)

Dr. Katrin Buss (invited)

Quality Assessor

Torsten Kneuss

Torsten Kneuss

Bayer

Dr. Claudia Heinl

Dr. Claudia Heinl

SCHOTT

Dr Deolinda Izumida Martins

Dr Deolinda Izumida Martins

West Pharmaceutical Services

Vincent Jeanguyot

Vincent Jeanguyot

Novartis

Note: All times mentioned are CET.

Zielsetzung

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.

Hintergrund

There are a great number of regulatory requirements on pharmaceutical packaging materials, in the pharmacopoeias, the GMP regulations, in the FDA guidances, etc. Packaging materials also have to be described in the registration process of a drug product according to the requirements of the CTD.

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.

Furthermore, the pharmaceutical manufacturer has to guarantee that only such packaging materials are used that are correctly printed on, in conformity with the specifications and in compliance with the regulatory requirements.

In order to determine the scope of the tests for the quality control of pharmaceutical packaging materials, Defect Evaluation Lists have proved efficient. The responsibility for the tests lies now more and more with the manufacturers of packaging materials, while the pharmaceutical industry tries to reduce testing & sampling at the same time. However, as a precondition for this, additional QA measures, like supplier qualification, audits and supply agreements, have to be taken.

Zielgruppe

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.

Technical Requirements

We use Webex Events 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.

Programm

Pharmaceutical Packaging Systems - Part 1 - Development - Live Online Training

Gesamtes Programm als PDF herunterladen

Day 1 - 26 November 2024
 
Regulatory Framework applicable to Pharmaceutical Packaging Materials
  • Code of Federal Regulations (CFR)
  • US Guidance for Industry: Container Closure Systems
  • EC Guidance: Plastic Immediate Packaging Materials
  • Compendial Standards (USP, Ph. Eur., JP)
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
 
 
Day 2 - 27 November 2024
 
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

ECA-Member*: € 1390,-
Non ECA Member*: € 1590,-
EU/GMP Inspectorates*: € 795,-
APIC Member Discount*: € 1490,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
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Teilnehmerstimmen - das sagen andere über unsere Seminare:

"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen.
Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.”
Christian Wagener, WAGENER & CO. GmbH
GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024

„Danke für das tolle und interessante Seminar! Ich nehme mir fachlich total viel mit und habe viele tolle Menschen kennengelernt.“
Melanie Schifferer, DAIICHI SANKYO EUROPE GmbH
Batch Record Review (QS 23)
September 2024

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023

„Interessante Themen, gut vorgetragen, die eigenen Erfahrungen der Vortragenden helfen, dies noch besser nachzuvollziehen.“ „Gute Gestaltung der Workshops, das Zusammenarbeiten in Gruppen und der Austausch mit anderen hilft sehr.“
Manuela Seibert, Merck, GMP-Leadauditor/in (FA 2), April 2024

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