Live Online Training: Continuous Verification in Pharmaceutical Analysis

Live Online Training: Continuous Verification in Pharmaceutical Analysis

Course No 18833

All times mentioned are CEST.

Costs

ECA-Member: EUR 590,--
Regular Fee: EUR 690,--
EU/GMP Inspectorates: EUR 590,--
APIC Member Discount: EUR 640,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Joachim Ermer, Ermer Quality Consulting, Germany

Objectives

Besides regulatory expectations, 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 on-going performance verification is also intended to be included in the revision of the ICH validation guideline Q2.

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.

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

Regulatory Requirements and the Lifecycle Concept of Analytical Procedures
  •  FDA validation guidance (monitoring and trending)
  •  Draft USP information chapter <1220>
    •  Stage 1: Procedure Design and Development
    •  Stage 2: Procedure Performance Qualification
    •  Stage 3: Ongoing Procedure Performance Verification
  •  ICH Q2-Revision and Q14 Analytical development (concept paper)
Workshop
Sources of data and information on analytical performance

Evaluation of Procedure Performance
  •  Indicators of performance (conformity, validity, analytical control parameters)
  •  Risk-based identification of suitable performance parameters (SST, from sample analysis, control samples)
  •  Evaluation of information and data (OOS, invalid results, control charts, average parameters)
  •  Continual improvements
Monitoring and Trend Analysis
  •  Control charts (Shewart, range, standard deviation, combined, CUSUM)
  •  Pragmatic establishment of rules and limits (statistical, empirical)
  •  Trend analysis for stability results
  •  Examples

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