PDA EU00186 How to Handle Test Sets in Visual Inspection - Training / Workshop von PDA Europe gGmbH

Inhalte

Visual inspection test sets are essential for operator qualification and validation of visual inspection systems to be compliant with all pharma regulations, GMP requirements, and company-specific quality standards.

As test sets are individually designed and developed based on the product specifications as well as the manufacturing processes, no “one-size fits all” solution is possible. Its variability regarding size, content, and purpose makes management along the life cycle of a test set even more difficult. Starting from the creation of a test set to the visual evaluation up to the correct application along the manufacturing process reflects the high level of complexity.

This training course will take place at the Körber Pharma Inspection Site in Markt Schwaben, Germany. In order to fully understand the “why do I need”, “when do I need”, and “what do I need” combined with “how do I create”, “how do I apply”, and “how do I manage” a test set, experts will share their expertise based on best practices and years of experiences within the pharmaceutical industry.

Visual inspection test sets are essential for operator qualification and validation of visual inspection systems to be compliant with all pharma regulations, GMP requirements, and company-specific qual ...

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Lernziele

  • Understanding compliant VI test set design, qualification, and lifecycle management: purposes, process, and applications
  • Understanding the current regulatory expectations and quality risk management of VI and particle control
  • Understanding the different types of defects and their potential impact on quality
  • How to develop a test kit for the visual inspection (risk analysis, what defects should be included)
  • How to build up a test kit for the visual inspection (practical introduction)
  • How to handle a test kit (shelf life, storage and more)
  • Hands on experience on manual & automatic inspection
  • The importance of a defect sample set for an AVI project
  • How to handle DIP on AVI
  • Understanding compliant VI test set design, qualification, and lifecycle management: purposes, process, and applications
  • Understanding the current regulatory expectations and quality risk management ...
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Zielgruppen

  • Operators/Coordinators
  • Managers

SG-Seminar-Nr.: 6767327

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