Quality by Design and Single-Use Air Sampling Approaches

On Demand Webinar

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.

Presenter

Gilberto Dalmaso

PhD - Senior Advisor and Pharma Customer Advisory Team Manager

Gilberto has over 25 years’ experience in pharmaceutical microbiology and sterility assurance. Today he is a reporter to numerous symposia on the microbiology and Pharma in Europe and United States. Dr. Dalmaso is the Global Consultant and Subject Matters Experts Team Manager for Particle Measuring Systems. In this role and with his team of subject matters experts, he collaborates and consults with pharmaceutical companies to develop and implement science-based strategies and processes that utilize Quality by Design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes.

Presenter

Dr. Frank Panofen

PhD, Life Science Division, Product Line Manager Microbials, Particle Measuring Systems

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 a certified Microbiological Laboratory Manager from ECA.