Validation in Pharmaceutical Analysis - Live Online Training
Lifecycle Concept, ICH Q2(R2) & Training Materials, USP <1225> Revision
Wednesday, 13 May 2026 9 .00 - 17.00 h
Course No. 22744
Speakers
Dr Joachim Ermer
Ermer Quality Consulting
USP <1225> Revision: Useful Complementation, Interpretation & Remediation of ICH Q2(R2)
Target Group
Managers and professionals from Quality Control, Quality Assurance and Regulatory Affairs who want to deepen their understanding of GMP requirements for analytical procedure validation.
Participants looking for practical recommendations for efficient study design, execution and evaluation of analytical Validation.
Objectives
The regulatory requirements to validation of analytical procedures utilised for release and stability studies of drug substances and drug products are described in the ICH guideline Q2(R2). However, its degree of detail is rather low, and the examples provided in Annex 2 often lack orientation beyond the guideline text. Therefore, this Live Online Training provides besides these regulatory expectations practical interpretation and recommendations for demonstration of the suitability of analytical procedures. The revision of the USP General Information Chapter <1225> “Validation of Analytical Procedures”, published November 2025 provides urgently needed interpretation of some neglected aspects in the ICH guideline Q2(R2), for example with respect to precision levels, replication strategy for the reportable result, and acceptance criteria.
The ICH Q2(R2)/Q14 Training Materials published in July 2025 is critically discussed, emphasizing some deficiencies and gaps, for example the inappropriate mixing of precision levels, or the lack of orientation how to derive appropriate acceptance criteria or to establish a suitable replication strategy.
A rational and efficient validation approach is ultimately based on the respective routine application, which should be reflected in the validation design. This includes the identification of the relevant performance parameters, the selection of appropriate tests and calculations and, in particular, the establishment of acceptance criteria for the Evaluation.
These recommendations are illustrated by practical exercises, demonstrations, and interactive polls/discussions (Mentimeter based).
Technical Requirements We use Webex for our live online training courses and webinars. At 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 1,090 APIC Members EUR 1,190 Non-ECA Members EUR 1,290 EU GMP Inspectorates EUR 645 The 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.
Testimonials
