Quality by Design and Single-Use Air Sampling Approaches

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.

Speakers:

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.