Webinar Series Validation in Pharmaceutical Analysis: Accuracy
Friday, 29 May 2020 10.00 - 11.30 h
Course No. 18036
Speakers
Dr. Joachim Ermer
Ermer Quality Consulting
Important: Deadline is 12 noon on 28 May 2020 You will find all webinars of this series in this overview
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. The latter is one of the reasons for the just started revision of the guideline, as well as inclusion of lifecycle and risk management aspects, which gained increasing attention in the last years.
Target Group
The webinar 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 succesful analytical validation.
Technical Requirements
For our 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
Besides regulatory expectations, the Webinar series provides practical recommendations and orientation for demonstration of the suitability of analytical procedures. A rational and efficient validation approach is ultimatly 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.
The following topics will be covered in the part „Accuracy“:
Regulatory requirements
Error types, link between systematic (bias) and random error
Specificity
Separate and combined evaluation of accuracy and precision
Simple (point estimator) and statistical evaluation (confidence intervals)
Comparison and recovery
Statistical significance and equivalence tests
Variability and expected difference between means
Acceptance criteria for assay and impurity determinations
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