Validation in Pharmaceutical Analysis: ICH Q2 Revision, Lifecycle Concept, Precision, and Accuracy - Online Training Recording
Course No. 21706
Speakers
Dr. Joachim Ermer
Ermer Quality Consulting
Objectives
Besides regulatory expectations, in particular the new ones in Q2(R2), this Live Online Training provides practical recommendations and orientation for demonstration of the on-going suitability of analytical procedures. 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.
Both trainings focus on the relevant performance characteristics, taking the - long-awaited - revision of the ICH Q2 guideline as well as the new Q14 guideline Analytical Procedure Development from November 2023 into consideration. Lifecycle aspects will be included in the discussion.
Background
According to EU GMP Guide Part 1, Chapter 6, Quality Control (6.15) and US 21 CFR 211.194, analytical procedures must be suitable for their intended purpose. 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. The lifecycle aspect of validation is treated in Q2(R2) rather as the “poor stepchild”, but covered better in the new ICH Guideline Q14 Analytical Procedure Development, and – in a true holistic way - in the USP General Information Chapter <1220> The Analytical Procedure Lifecycle.
Target Group
These Live Online Training Courses are aimed at executives and employees from Quality Control, Quality Assurance, and regulatory who want to gain a better understanding of the GMP requirements for validation of analytical procedures, in particular the new aspects and requirements of the revised ICH guideline Q2(R2), and who are interested in practical recommendations for an efficient design, execution, and evaluation of a successful analytical validation.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programme
Lifecycle Concept, ICH Q2 Revision and Q14
The Analytical Procedure Lifecycle – USP General Information Chapter <1220> and ICH Q14
Overview on important adjustments and complementations in ICH Q2(R2)
Reportable range
Analytical Target Profile
Requirements to the analytical Performance
Error types
ATP in Q2(R2) and Q14
Evaluation of performance parameters (simple, statistical)
Acceptance limits for assay - Derivation from probability, measurement uncertainty, tolerance factors - Design of precision studies and calculations - Uncertainty of precisions: point estimators and confidence intervals
Optimisation of precision by averaging (replication strategy) - Precision of the reportable value (small molecules,bioassay) - Assay for small molecules, bioassay
Accuracy
ICH Q2(R2): Comparison, recovery, and technologyinherent justification, combined evaluation of accuracy and precision
Testimonials