Webinar: Microbiological Control of Non-Sterile Drug Products and Raw Materials
Thursday, 23 May 2019 14.00 - 15.30 h
Course No. 17229
Speakers
Dr. Marcel Goverde
MGP Consulting
Background
Although the microbiological testing of non-sterile drug products and raw materials are clearly defined by the Pharmacopeia there are still some challenges which can appear during development or routine testing. Therefore, it is up to the pharmaceutical company to have clear written procedure on the method itself as well as on the handling of special cases. The goal of this webinar is to give an overview of the methods described in Ph. Eur. chapter 2.6.12 and 2.6.13 or USP chapter <61> and <62>. Additionally, a short introduction to the new method for the testing of Burkholderia cepacia complex drafted in USP chapter <60> is given.
Target Group
The webinar targets to new staff who are in relation of pharmaceutical microbiology, but also to QA or QP who need to evaluate the data gathered by their microbiologicwal lab or CMO as well as regulatory staff in charge of microbiological specifications.
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.
Programme
This webinar aims at giving you a comprehensive but still compact overview about the microbiological testing methods of non-sterile products according to the harmonized chapters of the Pharmacopeia.
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