Dr Marcel Goverde, MGP Consulting
Dr Goverde holds a PhD in Biology and runs since 2011 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.
Microbiological testing is present in several stages during development and manufacturing of any drug product or raw material (excipient, drug substance, primary packaging). There is huge number of different microbiological tests. The goal of this webinar is to give an overview of the most important microbiological tests (such as sterility test, bioburden test, identification and evaluation of isolates, endotoxin testing, growth promotion test, preservation test, environmental monitoring or container closure integrity) and will give some ideas on alternative or rapid microbiological testing.
The webinar targets to new staff who want to get an overview on microbiological quality control, to QA or QP who need to evaluate the data gathered by their microbiological lab or CMO as well as regulatory staff in charge of microbiological specifications.
This webinar aims at giving you a compact overview about the most important microbiological testing methods of sterile as well as non-sterile products according to the current regulations.