Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals - Live Online Training
10/11 September 2025
Seminar-Nr. 21886
Referent:innen
Dr. Raphael Bar
BR Consulting
Dr. Thomas Fürst
Boehringer Ingelheim
All times mentioned are CEST.
Zielsetzung
This Live Online Training will give an overview of tools that a Qualified Person (QP), Quality Assurance personnel or a Product Manager/Manufacturer should have in order to evaluate the impact of excursions from the storage label instructions on the disposition of distributed shipments of pharmaceutical/biopharmaceutical products.
Hintergrund
The formal stability studies of pharmaceuticals and biopharmaceuticals are a well-established discipline and they are regularly conducted at precisely monitored conditions of temperature (within 2 °C) and of humidity (within 5% RH) under cGMP. However, the inevitable processes of shipping and distributing medicines from the manufacturer to wholesaler to warehouses to the end user via air, ship or car exposes often the shipments to temperatures and humidity different from the label storage conditions. For instance, how would you handle a shipment that was exposed to a varying temperature up to 61oC in the airport for an accumulated duration of several days? How would you evaluate the quality of a refrigerated injectable that was exposed to near zero or freezing temperatures for a few hours? Would you release or reject such a shipment which may cost hundreds of thousands of dollars?
Shipping/distribution of a medicine is considered a “mobile storage”. However, a temperature excursion outside the label instructions may also be considered a ‘trauma” inflicted on the medicine and this may impact the quality of the newly arrived shipments. But, the big question remains: how would that ‘trauma” affect the quality at the end of the declared shelf life of any pharmaceutical and of a biopharmaceutical in particular? Will the long-term impact lead to a “hidden OOS”? This training will address these aspects. In addition, the course also includes two case studies and a session with video presentations. Further, a set of Q&A sessions will follow the lectures. Thus, take advantage of this opportunity to pose your questions.
Zielgruppe
This Live Online Training will be of significant value to
Qualified Persons
Quality Assurance personnel
Pharmacists
Project coordinators/product managers
Stability testing personnel
Stability program logistics personnel
R&D personnel involved in product development
Date & Technical Requirements
Date of the Live Online Training
Wednesday, 10 September 2025 from 09.00 – 17.00 h CEST Thursday, 11 September 2025 from 09.00 – 13.00 h CEST
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/onlinetraining- 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.
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