This training is directed at professionals 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 moderately experienced staff.
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
This training course provides a focused introduction to the fundamentals of manual visual inspection of injectable products. It covers the organisation of visual inspection, operator training and qualification, and the inspection process itself, with a clear link to current compendial expectations (including USP <790>, USP <1790> and Ph. Eur. 5.17.2) and EU GMP Annex 1. The course also addresses the practical implementation of test kits for training and qualification, the correct use of AQL testing as part of batch release, and the trending and monitoring of inspection data, including the controlled re-inspection of defect fractions.
Programme
General Requirements
Requirements of the different Pharmacopeia
Defect categorisation
Test kits for training, qualification and routine
Manual Inspection
Organisation of the manual inspection
Training of personnel
Qualification of personnel
Standardisation of working conditions
AQL testing in the manual inspection
Trending of inspection data & batch release
Further Information
Technical Requirements Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT) ECA Members EUR 590 Non-ECA Members EUR 690 EU GMP Inspectorates EUR 490 The conference fee is payable in advance upon receipt of invoice.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
