Pre-Conference Course "Fundamentals of Visual Inspection & AQL Testing"

Pre-Conference Course "Fundamentals of Visual Inspection & AQL Testing"

Vienna, Austria

Course No 16051


Costs

Non-ECA Members: EUR 790,--
ECA Members: EUR 590,--
EU GMP Inspectorates: EUR 395,--
APIC Members (does not include ECA membership): EUR 690,--

(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 Helmut Gaus, Director Quality Control at Boehringer Ingelheim

Dr Tobias Posset, Roche

Programme

The training course on visual inspection which takes place the day before the Particles Conference gives you an understanding of the fundamentals of visual inspection of injectable products, applicable to manual and automated inspection. You will also learn how to implement an automated system on the basis of the manual inspection. The course also includes an AQL training, that is you will learn how to use AQL tables to set defect limits and how to evaluate batch inspection data.

Skills you will develop through the course:

  • Ensuring GMP compliance in manual inspection
  • Setting up a qualification strategy for automated systems
  • Usage of statistical tools for assessing inspection data
  • GMP-compliant routine operation of automated systems
Content of the course in detail:

General requirements
  • Requirements of the Pharmacopeia
  • Defect categorisation
  • Test kits for training, qualification and routine
Manual Inspection
  • Qualification and training of personnel
  • Standardisation of working conditions
  • AQL in the manual inspection
From Manual to automated inspection
  • Usage of the Knapp and the modified Knapp test
  • Cross validation during the PQ phase
Automated inspection
  • Importance of particle detection rates
  • System-Suitability, Requalification and revalidation

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