Stability Testing for Drug Substances and Drug Products - Live Online Training
12/13 November 2025
Course No. 22028
Speakers
Dr. Cornelia Nopitsch-Mai
formerly Quality Assessor
Dr Thomas Uhlich
Bayer
Dr. Josef Hofer
exdra
Dr. Thomas Fürst
Boehringer Ingelheim
Dr Ulli Backofen
Boehringer Ingelheim
Dr. Heiko Brunner
Hamburg
All times mentioned are CET.
Objectives
This Live Online Training is intended to provide information on different aspects of stability testing. The course will be opened by an overview of stability testing with a special focus on the ICH Guidelines. In the subsequent presentations, important aspects of stability testing for biologicals and throughout drug development are discussed. Another lecture focuses on stability testing for Drug Substances, followed by a talk on Drug Products. In a further presentation, the focus lies on to the various aspects of submitting stability data. Finally, statistical considerations will be covered in another lecture.
Background
Analytical methods that were not “stability-indicating” are frequently cited in FDA 483s and Warning Letters. This conference will thus address how to set impurity limits for related substances and degradation products based on method capability and stability results.
The analytical result, which will be compared to the specification, is affected by the variability of the measurement itself and depends also on the sampling process and on the variability of the manufacturing process of the tested product itself. This makes statistical considerations essential and consideration of the associated measurement uncertainties vital when setting or complying with specifications.
Finally, specifications for the API (drug substance), excipient(s) and the drug product are part of the quality section of the marketing authorisation application which has to be submitted to the competent authority.
Target Group
This Live Online Training is of particular interest to specialists from QA, QC and Regulatory Affairs departments of the API and pharmaceutical industry and CROs as well as to members of the EU inspectorates and authorities. Participants have the opportunity to exchange their experiences they gained with the different aspects of ‘specifications’ with the experts from the API and pharmaceutical industry as well as with members of competent authorities.
Date & Technical Requirements
Date Wednesday, 12 November 2025, 14.00 – 17.00 h CET Thursday, 13 November 2025, 09.00 – 16.30 h CET
Technical Requirements We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-trainingtechnical-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.
Testimonials
Seminar Programme as PDF