Important: Registration Deadline is 12 noon on 29 September 2021.
Background
An important aspect of the analytical lifecycle management is a systematic (quality-by-design) method development to gain an enhanced understanding of the procedure’s performance. This is the basis to establish measures and controls of sensitive parameters in order to ensure the required performance during routine application. One aspect of this Analytical Control Strategy is a science-based establishment of the number of replicates of the routine method, i.e. the replication strategy.
Target Group
Technical Requirements
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
The following topics will be covered:
- Statistical background – precision of the mean (standard error)
- Application to multiple precision levels & bioassays
- What is the practical effect of increasing the number of determinations (dependence on relative variance contributions)
- Optimisation under consideration of the uncertainty (confidence
- interval of precision)
- Prerequisites for an appropriate establishment of the replication
- strategy (reliability of the variance contributions from precision studies)
- Consideration of regulatory expectations- FDA (CDER) “averaging issue”
ECA-Member*: | € 249,- |
Non ECA Member*: | € 299,- |
(All prices excl. VAT). Important notes on sales tax.
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Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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