Validation in Pharmaceutical Analysis: ICH Q2 Revision, Lifecycle Concept, Precision, and Accuracy - Online Training Recording

Costs

*ECA-Member:**	EUR 590,--
*Regular Fee:**	EUR 690,--
*EU/GMP Inspectorates:**	EUR 590,--
*APIC Member Discount:**	EUR 640,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Dr Joachim Ermer, Ermer Quality Consulting, Germany

Objectives

Besides regulatory expectations, these Live Online Training Courses provide 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 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(R1). However, its degree of detail is rather low, and the discussion is mainly focused on chromatographic methods. A broader consideration of other analytical techniques as well as alignment with lifecycle aspects is intended with the revision of Q2. The latter is also in the focus of the new ICH Guideline Q14 Analytical Procedure Development and is already content of 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, are interested to participate in a discussion of the revised ICH guideline Q2, 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 presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

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)
Aspects of an efficient validation

Precision

Precision levels (system precision, repeatability, intermediate precision, reproducibility)
Precision in ICH Q2(R2)
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 technology-inherent justification, combined evaluation of accuracy and precision
Statistical significance and equivalence tests
Variability and expected difference between means
Acceptance criteria for assay

Workshop: Multiple Choice-Questions (from Publications)

How to avoid mistakes in Validation

Recording from 14.03.2023
Duration of the recording: approx. 3.5 h

Go back