Dr. Joachim Ermer
Ermer Quality Consulting
Referent:innen
Zielsetzung
Besides regulatory expectations, this Training course 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.
This Training focusses on the parameters Accuracy, Specificity, Linearity and Quantitation Limit.
This Training focusses on the parameters Accuracy, Specificity, Linearity and Quantitation Limit.
Hintergrund
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. The latter is one of the reasons for the started revision of the guideline, as well as inclusion of lifecycle and risk management aspects, which gained increasing attention in the last years.
Zielgruppe
This Training is aimed at executives and employees from Quality Control, Quality Assurance, and regulatory who want to gain a better understanding of the GMP requirements as well as current trends and 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:
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.
Training Course Documentation and Certificate:
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.
Programm
Accuracy
- Comparison and recovery
- Statistical significance and equivalence tests
- Variability and expected difference between means
- Acceptance criteria for assay and impurity determinations
- Separate and combined evaluation of accuracy and precision
Specificity
- Comparison and (chromatographic) separation
- Samples for investigation of specificity
- Peak purity investigations
Linearity
- Gaps in the ICH Q2-Guideline
- Requirements to calibration models
- linear single-point and multiple-point calibration,
- non-linear calibration
- standard addition
- Statistical calculations (regression, suitable parameters)
- Acceptance criteria for calibration function
- residual and sensitivity plot
- ordinate intercept
Detection and Quantitation Limit
- Determination of the quantitation limit (blank procedures, from linearity, from precision)
- Is less more?
- Capability and requirement based quantitation limits
- Consideration of practical relevance (samples, concentration range for linearity approaches)
Workshop: Multiple Choice-Questions (from Publications)
- How to avoid mistakes in validation
Recording from 30 June 2021
Duration of Recording: 3h 05min
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 590,- |
| APIC Member Discount*: | € 640,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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