Dr Helmut Gaus, formerly Boehringer Ingelheim
Dr Tobias Posset, Roche
The AQL Inspector’s Rule - A tool for conducting AQL Testing.
Pre-Conference Course "Fundamentals of Visual Inspection & AQL Testing"
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.
For that purpose all participants of the Pre-Conference Course receive the AQL Inspector’s Rule as tool for AQL testing for free.The rule covers a wide range of AQL's with Normal, Tightened and Reduced inspection for both single and double sampling plans according to ISO 2859-1 (1999). The practical usage of this tool will be shown during the course.
Skills you will develop through the course:
Content of the course in detail:
- Ensuring GMPcompliance 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
- Requirements of the Pharmacopeia
- Defect categorisation
- Test kits for training, qualification and routine
From Manual to automated inspection
- Qualification and training of personnel
- Standardisation of working conditions
- AQL in the manual inspection
- Usage of the Knapp and the modified Knapp test
- Cross validation during the PQ phase
- Importance of particle detection rates
- System-Suitability, Requalification and revalidation
Dr Helmut Gaus, WinSol & former Director Quality Control at Boehringer Ingelheim
Dr Tobias Posset, Head of Production Support Roche Diagnostics