Environmental Monitoring (EM) is one of the key pillars to ensure aseptic manufacturing. It covers particle measurement and hygiene monitoring (air and surface sampling).
This two-day course is set up as a highly interactive event with hands-on lab training sessions and workshop sessions on risk analysis and design of Environmental Monitoring. The lecture part will cover current regulations, methods and devices.
All participants are invited to bring their own case studies or audit findings and questions to be discussed in the group..
The group has the unique opportunity to visit the calibration lab of CAS to see calibration of devices in action.
Who Should Attend
This course is designed for
- Lab Supervisors
- Manufacturing Supervisors
- QC Managers
- QA Managers
- Manufacturing Managers
- Lab Staff
- Auditors and Regulators
Upon completion of this course the participants
- have understood the principles of EM
- can explain different methods of EM (microbial, particles), standard and advanced methods
- have understood basic designs of EM program in facility or clean room
- are able to give input to / perform a risk analysis
- have understood impact of operator behaviour in cleanroom on EM
- can operate EM devices
- have understood principles of data trending and integrity
- have understood current guidelines and regulations (including Annex 1 revision)
Frank Panofen, PhD, Senior Consultant, Particle Measuring Systems
Over the last 15 years with Merck, Frank Panofen gained proven expertise in traditional microbiological topics like sterility testing and bioburden analytics and a long experience on the implementation and development of new rapid technologies for the pharmaceutical industry. Today, Frank is the Product Line Manager for Sterility Assurance/Microbiology products at Particle Measuring Systems, globally responsible for all products related to industrial microbiological testing, with a strong focus on environmental monitoring. He is certified Microbiological Laboratory Manager from ECA. Frank gained a Diploma in Chemistry from the University of Bielefeld and a PhD in molecular and cell biology from the University of Osnabrück.
Gilberto Dalmaso, PhD, Global Product Line Manager Microbiology & Sterility Assurance, Particle Measuring Systems
Gilberto Dalmaso has over 25 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK) where he started in 1984. Over his last five years with GSK, Gilberto led a series of initiatives implementing Process Analytical Technologies (PAT) and Rapid Microbial Methods (RMM). Today Gilberto is the Senior Advisor and Global Pharma Customer Advisory 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.
Marcel Goverde, PhD, Managing Director, MGP Consulting
Marcel Goverde gathered first work experience as scientific collaborator in the agro biological section of Novartis. From 2002-2010 he led several QC labs for microbiology at F. Hoffmann-La Roche Ltd. From 2010-2011 Marcel worked as a QC expert for microbiology at Novartis Pharma Ltd. Since 2011 he leads his own business for consulting, training, project and deviation management named MGP Consulting
GmbH. Marcel is a regular speaker at different institutions and has written several scientific papers. He is the Swiss expert in the EDQM group for modern microbiological methods since 2003. Marcel studied biology at the University of Basel, where he gained his PhD in 2001.