Fundamentals of Manual Visual Inspection - Online Training Recording
Course No. 20301A
Speakers
Dr. Helmut Gaus
WinSol
Objectives
This training course gives you an understanding of the fundamentals of visual inspection applicable to the manual inspection of injectable products. This covers the following aspects of visual inspection: organisation, training, qualification and the inspection process itself. You will also learn about AQL testing and trending of inspection data.
Background
The 100% visual inspection of sterile injectable products is a requirement originating from the Pharmacopoeias, e.g. from the US USP or the European PharmEur. But there is still confusion within the global Pharmaceutical industry with regard to the requirements for testing of visible particles. After the USP chapters <790> and <1790> were published, things have become much clearer, at least for the US. In Europe the new chapter 5.17.2 of the European Pharmacopoeia now also gives further advice. However, many questions remain, e.g. concerning training, qualification, detection capabilities and Organisation of the visual inspection and the AQL testing.
We will address those topics during the conference and discuss and answer questions on:
The latest compendial requirements concerning particulate matter
Compliance with the revised Annex 1 (draft)
Training and qualification of operators in the Manual inspection
Setup of test kits for training and qualification
Trending and monitoring of visual inspection data
Correct AQL testing as part of the batch release
Re-inspection of defect fractions
Target Group
This one-day training is directed at everybody involved in the manual 100% inspection of sterile injectables. As the fundamentals are explained in a very comprehensive way, the course is very popular with beginners and medium experienced staff.
Technical Requirements
We use Webex Events for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the Information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programme
General Requirements
Requirements of the different Pharmacopeia
Defect categorisation
Test kits for training, qualification and routine
Manual Inspection
Organisation of the manual inspection
Qualification of personnel
Training of personnel
Standardisation of working conditions
AQL in the manual inspection
Trending of inspection data & batch release
Recording from 28 June 2022 Duration of the recording: approx. 1,5 h
Testimonials