ECA Webinar: Microbiological Control of Non-Sterile Drug Products and Raw Materials

ECA Webinar: Microbiological Control of Non-Sterile Drug Products and Raw Materials

Heidelberg, Germany

Course No 17229


Costs

Non ECA Member: EUR 199,--
ECA-Member: EUR 149,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

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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