Continuous/Ongoing Verification in Pharmaceutical Analysis - Online Training Recording
Course No. 22741
Speakers
Dr Joachim Ermer
Ermer Quality Consulting
Target Group
This 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 a continuous analytical performance verification.
Objectives
Besides regulatory and compendial expectations, as discussed in the just published draft of a new USP General Information Chapter <1221> “Ongoing Procedure Performance Verification” this Live Online Training provides practical recommendations and orientation for demonstration of the continual suitability of analytical procedures across the analytical procedure lifecycle. 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 identify, investigate and evaluate suspect (out-of-trend, OOT) 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“ (2015), 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 USP General Information Chapter <1220>. The ongoing performance verification is also discussed in the ICH Guideline Q14 “Analytical Procedure Development” (2023), and in the just published ICH Training Materials (Module 4 and 5).
Programme
Regulatory Requirements and the Lifecycle Concept of Analytical Procedures
FDA validation guidance (2015)
USP General information chapter <1220> - Stage 1: Procedure Design and Development - Stage 2: Procedure Performance Qualification - Stage 3: Ongoing Procedure Performance Verification
ICH Q14 “Analytical procedure development”
Draft USP General Information Chapter <1221> “Ongoing Procedure Performance Verification”
Workshop Sources of data and information on analytical Performance
Evaluation of Procedure Performance
Risk management: Factors related to analytical procedure criticality & risk-based performance monitoring plans
Analytical Procedure Performance Metrics (conformity, validity, analytical control parameters)
Risk-based identification of suitable performance parameters (SST, from sample analysis, control samples)
Links to Analytical Procedure Control Strategy (ICH Q14, Training Module 4)
Continued verification of ATP requirements and periodic analytical performance assessment
Continual improvements
Monitoring and Trend Analysis
Control charts (Shewhart, range, standard deviation, CUSUM)
Statistical out-of-control rules
Pragmatic establishment of trending rules and limits (statistical, empirical)
Examples
Further Information
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.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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