Hintergrund
For this reason, the Pharmaceutical Microbiology Working Group of the ECA decided two years ago to prepare a supporting document that provides guidance on how to deal with such microbiological deviations based on the experience of its members and regulatory expectations. After the first chapter “Guidance for deviation handling of microbiological environmental monitoring excursions in non-sterile pharmaceutical manufacturing”, which has already been published, the second section, Endotoxin Testing Lab Investigations - OUT OF SPECIFICATION (OOS)/OUT OF TREND (OOT)/ATYPICAL RESULTS INVESTIGATIONS is finalized now and will be published shortly.
Zielgruppe
- Quality Assurance
- Quality Control
- Microbiology
- Contract Labs
- R&D
- Authorities
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
- Out of Specification (OOS)/Out of Trend (OOT)/Atypical
- Results Investigations
- Creating the Investigation Process Parameters
- OOS vs Invalid
- Performing the Laboratory Investigation
- How to use data generated by your company to proactively prevent OOS
Duration of the Recording: Appr.1,5 h
| ECA-Member*: | € 199,- |
| Regular Fee*: | € 249,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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