Jordi Iglesias, Technology and Market Development Manager, Charles River
The handling of deviations, i.e. Out of Specification (OOS), Out of Limit (OOL), Out of Trend or typical test results is unfortunately insufficiently described from a regulatory point of view. The only existing guideline of the FDA unfortunately does not refer to microbiological issues.
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.
This webinar is aimed at employees from the following areas
- Quality Assurance
- Quality Control
- Contract Labs
who are involved in the control of Endotoxins, administration of deviations/root cause analysis, batch release and audits and inspections.
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.
During the webinar you will have the opportunity to learn about the content of the new guideline:
- 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