Tobias Posset
Roche Diagnostics
Referierende
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Zielgruppe
The target group of this shortcut 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.
Zielsetzung
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 Shortcut we want to show, how a GMP-compliant concept of a semi-automated inspection system and its qualification could look like.
With this Shortcut we want to show, how a GMP-compliant concept of a semi-automated inspection system and its qualification could look like.
Programm
Topics in this shortcut 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
Weitere Informationen
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Contacts
Questions regarding content:
Dr Robert Eicher, +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding Organisation:
Ms Julia Grimmer, +49 6221 84 44-44, julia.grimmer@concept-heidelberg.de
Duration of the shortcut: 1h 30m
Recorded in June 2020
Please note:
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Teilnahmegebühr
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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