recorded on 23.05.2019
|Non-ECA Members:||EUR 249,--|
|ECA Members:||EUR 199,--|
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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.
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.
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.
Dr Marcel Goverde, MGP Consulting
Mr Goverde holds a PhD in Biology and runs his own company for consulting, training and project management in GMP-relevant areas with focus on microbiology, hygiene and deviation management. He gathered 8 year of work experience in microbiological pharmaceutical industry at F. Hoffmann-La Roche Ltd and another year as QC expert for microbiology at Novartis Pharma. Since 2003 Mr Goverde acts as a Swiss delegate in the EDQM group for microbiological and statistical methods and since 2011 as board member and deputy chair of the ECA Pharmaceutical Microbiology Working Group. He is a regular speaker at different institutions.