Quality by Design (QbD) is a well-known concept in the pharmaceutical industry to increase the overall quality of pharmaceutical drugs and increase patient´s safety. Controlling the quality of air inside an environmental monitoring program is a vital aspect of managing the risk towards the patient. 

This webinar will give you an insight into how QbD can be applied to microbiological monitoring using most recent advances in technologies, including single-use. We will introduce and discuss the concept of continuous viable air sampling following the guiding principles that are well known from the particle monitoring aspect.

Gilberto Dalmaso, PhD
Dr. Gilberto Dalmaso has over 25 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK).  In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today Gilberto is the Global Aseptic Processes Development Manager for Particle Measuring Systems, serves on the European PDA Committee, is a reporter to numerous symposia on the microbiology and Pharma in Europe and United States, and is an ISO 9001 and HACCP quality system auditor.


Frank Panofen, PhD
Dr. Panofen has a Diploma in Chemistry from the University of Bielefeld and a PhD in molecular and cell biology from the University of Osnabrück. He has expansive experience in the field of applied pharmaceutical microbiology and serves as the Sterility Assurance/Microbiology Product Line Manager at Particle Measuring Systems. Frank has been an invited speaker at international conferences including ECA and PDA, with a strong regulatory background in pharmaceuticals. He is s certified Microbiological Laboratory Manager from ECA.

Date / Time
Two dates and times are offered to reach our global clients:

  • October 13, 10:00 am Colorado MT / GMT - 0600           Register
  • October 20, 10:00 am Rome / CEST / GMT +0200           Register


Archived On Demand Webinars

The New EU GMP Annex 1 Revision 2017: Review, Insights and Feedback

Download this webianr to get a first look and review of the Annex 1 draft, released for comments. Our experts will be providing their comments and will want to hear your thoughts on this new version. 

learn more or download now

ISO 14644-1:2015 Revisions Summary

Learn about ISO 14644-1:2015 and how it affects your clean environment monitoring.

The recent revision of ISO 14644-1 introduced several changes for cleanroom classification and monitoring guidelines. Join us for a review of the changes and how they affect your environment monitoring.

learn more or download now

Identifying the best rapid microbial monitoring solution for your critical & ISO 5/ Grade A surfaces

Managers need the assurance that the surfaces in their facilities are aseptic. Gaining that knowledge in a fast and accurate way that also provides results for all surfaces, even and uneven, is a challenge.

learn more or download now

Identifying a safe and reliable microbiological air sampling solution for ISO 5 environments

Personnel pose the greatest risk of false positives in aseptic processing. The BioCapt® Single-Use eliminates false positives and costly investigations by preventing direct operator contact with the media plate.

learn more or download now