Dr Tobias Posset, Roche Diagnostics
Parenterals have to be 100% visually inspected. The semi-automated visual inspection is used for liquid and lyo vials and syringes since many years. Now, this type of inspection is getting more and more into the focus of GMP regulations and regulators. The requirements for manual or automated, camera-based inspections have become much clearer during the last 2-3 years with each relevant new chapter of the US and EU Pharmacopeias. But for the semi-automated visual inspection, being a hybrid of both methods mentioned above, this is not the case. Especially when it comes to inspection time per container, necessary computer validation and eye breaks etc.
With this Webinar we want to show, how a GMP-compliant concept of a semi-automated inspection system and its qualification could look like.
The target group of this webinar are professionals in quality assurance, technology and production who are entrusted with the implementation or operation of a semi-automated inspection system or its defense during audits & inspections.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Topics in this webinar cover conception, qualification and routine use of semi-automated visual inspection of parenterals.
- Qualification concepts for semi-automated 100% visual inspection including particle detection
- Dealing with particle detection and its probabilistic nature using semi-automated visual inspection
- A particle-threshold-study vs. particle detection using fixed predefined limits
- Qualification kits and defect libraries for the different qualification concepts
- Semi-automated visual inspection in daily Business
- eye breaks
- inspection times
- number of objects to be inspected
- Semi-automated visual inspection in compliance with USP<790>, Annex 1 and other cGMP regulations
Recording from 16.06.2020
Duration of recording: approx. 1.5 h.