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TOC/TN Cleaning Validation How to approach pharmaceutical cleaning validation by sum parameters – challenges and solutions

Content and goals of the Web Seminar

Duration: ~60 min
Language: English
Speakers:
Bernd Bletzinger, Product Manager TOC
Ann-Sophie Lehnert, Product Manager Software & IoT

This web seminar will address key challenges in TOC/TN cleaning validation in the pharmaceutical industry, including method sensitivity, proof of complete sample oxidation, compliance with pharmaceutical standards, calibration strategies in the trace range, and contamination risks for samples and QC/calibration standards. We will highlight international regulations and discuss how to establish reliable recovery rates for swab and last rinse techniques. Key software topics in this context will be covered, such as secure centralized data storage, Active Directory user authentication, method and result versioning, audit trails, electronic signatures, and role-based user management. In addition, we will present the solutions and services offered by Analytik Jena’s with multi N/C x300 series, including equipment qualification, software validation, and upgrade services.

Key Learning Objectives:

  • Methods of cleaning validations
  • Key challenges including method sensitivity, proof of complete sample oxidation, calibration strategies in the trace range, contamination risks for samples and QC/calibration standards.
  • Meeting pharmaceutical compliance standards

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