Ongoing Verification in Pharmaceutical Analysis - Live Online Training
Tuesday, 24 January 2023 14.00 - 17.00 h
Course No. 20398
Speakers
Dr. Joachim Ermer
Ermer Quality Consulting
All times mentioned are CET.
Objectives
Regulatory guidelines discuss expectations for an ongoing control and evaluation of the suitability of analytical procedures, but – fortunately – do not provide details how to do this. Thus, the practical implementation is up to QC and QA. This Live Online Training provides practical recommendations and orientation for demonstration of the on-going suitability of analytical procedures. In particular, efficient approaches will be presented to extract information and data from routine analysis. This will be illustrated with examples from quality control of chemical drug substances and biopharmaceuticals.
A comprehensive understanding of the real analytical performance is extremely helpful to investigate and evaluate suspect or out-of specification (OOS) results as well as for a continuous process Validation.
Background
According to the FDA-Guidance „Analytical Procedures and Methods Validation for Drugs and Biologics“, it should be continually assured that an analytical procedure remains fit for its intended purpose throughout its application. This includes an ongoing program for routine monitoring of analytical performance data, and the systematic evaluation of changes with the objective to evaluate regularly the need for optimization and revalidation, if needed. These activities belong to stage 3 of the analytical lifecycle management as discussed in the draft of the new USP information chapter <1220>. The importance of such a monitoring to identify potential failures and adverse trends as well as ensure an efficient management of changes is also discussed in the draft of the new ICH guideline Q14 “Analytical procedure development”.
Target Group
This Live Online Training is aimed at executives and employees from Quality Control, Quality Assurance, and production who want to gain a better understanding of the GMP requirements as well as current discussions with respect to the lifecycle management of analytical procedures and are interested in practical recommendations for an efficient design, execution, and evaluation of an ongoing analytical performance verification.
Technical Requirements
We use Webex Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programme
Regulatory Requirements and the Lifecycle Concept of Analytical Procedures
FDA validation guidance (monitoring and trending)
USP General information chapter <1220> (valid May 1st, 2022)
Testimonials