Stability of Test Solutions - Webinar Recording

Stability of Test Solutions - Webinar Recording

Costs

ECA-Member*: EUR 199,--
Regular Fee*: EUR 249,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

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

Background

According to EU GMP Guide Part 1, Chapter 6, Quality Control and US 21 CFR 211.160, analytical procedures must be designed to ensure that drug products meet the quality standards and the specifications with respect to strength and purity defined in the marketing authorisation. This includes a suitable control of analytical procedure components such as reagents, solvents, standard and sample preparations to ensure an accurate and reliable analytical result. Thus, the shelf-life and storage conditions of standard and sample solutions should be demonstrated, as discussed in the USP General Information Chapter <1226>“Verification of compendial procedures“.

Target Group

The webinar targets executives and staff in quality control laboratories and quality assurance, who want to get an overview on GMP requirements with respect to stability and expiry dating of reagents, solvents, standard and sample preparations, as well as their efficient practical implementation.

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.

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

Besides regulatory expectations, the Webinar provides recommendations with respect to stability investigations of test solutions for qualitative and quantitative use. Suitable stability study designs, data calculations and assessments will be presented, in order to achieve a reliable and traceable shelf-life Determination.

The following topics will be covered:
  • Requirements to solutions for qualitative and quantitative use
  • Correspondig addition to USP General Information Chapter <1226> “Verification of compendial procedures“ (valid December 1, 2019)
  • What changes are acceptable for qualitative and quantitative use?
  • Appropriate evaluation of stability results. Why is the assessment of individual results not suitable?
  • Evaluation of stability data by averaging and regression
  • Determination of the shelf-life of standard and sample solutions
 
Recording from 06 May 2020
Duration of recording: 1,5 h.

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