Zero-effort Analytical Method Validation

C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Product Manager VALIDAT, Senior Software Architect, Head of Method Validation, iCD. GmbH & Co. KG
    Biography
      Jürgen Voorgang studied Mathematics at the University of Bonn with the focus on probability theory and stochastic. He developed the VALIDAT Method Validation software in the late eighties for pharmaceutical und chemical businesses during his freelancing work for international companies. After founding his companies headwork GbR and headwork-consulting GmbH he continued developing scientific software and introduced VALIDAT as the market leading software package for advanced method validation. Beginning of 2005 he merged with iCD. GmbH and now serves as the Head of Method Validation and VALIDAT Product Manager. He provides conference and training lectures as well as consulting for method validation with focus on ISO 17025, ICH and 21 CFR Part 11 for regulated businesses.

    Abstract

    Analytical Method Validation work is based on a variety of guidelines and requirements hence being time-consuming and stressful. Reducing this work and improving efficiency while ensuring the highest level of data integrity is welcome by both QA and laboratory – but how can this be achieved? Doing method validation is much more than just calculating results – it’s setting up your testing workload, both simple and flexible, with final documentation matching customer expectations as well as regulatory and industry requirements. The key for an optimized workflow is predefining all aspects of typical method validation work by means of powerful software workflow templates that reduce new projects to a matter of a few clicks. Such templates follow your SOPs and structure your tasks to optimize efficiency and compliance. Communication with your laboratory equipment (CDS, LIMS, ECM, ERP, DMS) should be automatic and easy with manual intervention limited to a minimum. While templates define routine work, it’s critical to allow flexibility for each new project – additional calculations, graphics and report extensions should be added easily. Since your data is worth being protected and comprehensible all this must be accompanied by a maximum level of data integrity, which means strict access control, full traceability, version history and full 21 CFR Part 11 compliance. This presentation will provide guidance and show optimized software workflows saving at least 70% of your time compared to performing these tasks manually.

    Learning Objectives:

    1. Analytical method validation – requirements and data integrity

    2. Establishing an optimized workflow with minimum effort

    3. Integrate and embed your method validation workflow into your lab environment


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