This course is directed at staff from sterile operations involved in the 100% inspection process, that is production, quality and engineering. But also suppliers of primary packaging materials and inspections technology are target group of this Event.
Objectives
The training course on visual inspection which takes place before the 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 based on manual inspection and how to qualify it
Skills you will develop through the course:
Ensuring GMP-compliance in manual inspection
Setting up a qualification strategy for automated systems
GMP-compliant routine operation of automated systems
Programme
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
Evaluation matrices
Automated Inspection
Importance of particle detection rates
System-Suitability, Requalification and revalidation
Evaluation of Inspection Data & Batch Release
Trending of inspection results
AQL Testing
Re-inspection – allowed or not?
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 1,090 APIC Members EUR 1,190 Non-ECA Members EUR 1,290 EU GMP Inspectorates EUR 645 The conference fee is payable in advance upon receipt of invoice.
Save 400 EUR when booking pre-conference course and conference together.
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
