Microbial Monitoring Solutions
Prepare Your Contamination Control Strategy (CCS) for EU GMP ANNEX 1
While the new Annex 1 is still in draft stage, the drafts tell us clearly where the committee is heading as far as priorities and gives us guidelines that we can apply now to your Contamination Control Strategy (CCS) (including a cleanroom monitoring plan) to be ready for the final Annex 1 update release. The New Annex 1 has some critical changes that are important to understand and start applying. While the drafts cover many areas of environmental monitoring in-depth, this webinar by Particle Measuring Systems (PMS) experts focuses on the Viable/Microbial Air Monitoring aspects including:
- Designing an effective Contamination Control Strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles.
- Newest Annex 1 Single Use Requirements relevant solutions
- Microbial Plate Incubation and Pharmaceutical Risk Assessments
- Importance of Continuous Viable Air Monitoring
- How the underlying need of a Quality Risk Management (QRM) approach, along with Risk Assessments based on science are to be the fundamental principles driving decisions to protect product quality
- When, Where, and How to do Environmental Monitoring and a cleanroom monitoring plan.
- Changes in Viable Monitoring Requirements
- Solutions to meet these cleanroom monitoring requirements
- Concepts regarding the requirements for a Pharmaceutical Risk Assessment to set appropriate Microbial Plate Conditions
- Much more!
During the live webinar we had several questions submitted and made these into an Annex 1 Microbial FAQ paper that you can access at any time.
Complete the form to access the on-demand webinar.
Ready to get started with a cleanroom monitoring plan and Contamination Control Strategy? Learn about Particle Measuring Systems PMS complete environmental monitoring solutions for Pharmaceutical Manufacturers.
Get started with your cleanroom microbial data collection and management. Particle Measuring Systems has a full suite of options for you:
- Cleanroom Contamination Control Advisory services
- Microbial impactors, including single-use for continuous sampling
- Active Air samplers
- Data management
Particle Measuring Systems has complete cleanroom contamination control solutions to help you meet EU GMP including:
- Our Contamination Control Advisory Services can conduct an expert Risk Assessment for your pharmaceutical processes
- PMS cleanroom particle counters including portable/mobile and fixed/remote
- Microbial monitors including portable/mobile, fixed/remote, and single-use.
- Data management software from Particle Measuring Systems
- Customizable, turnkey Facility Monitoring Systems (FMS)
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.
PRESENTER
Giulia Artalli
Global Product Line Manager, Particle Measuring Systems
Dr. Artalli has a degree in biology from the University of Milan with over 20 years’ experience in Microbiology, specifically for pharmaceutical applications.
Dr. Artalli has covered different roles acquiring knowledge on different topics useful for supporting customers in their needs; she is a Global Product Line Manager at Particle Measuring Systems for the Microbiology product line.
PRESENTER
Paola Lazzeri
EMEA Field Application Specialist Sterility Assurance/Microbiology, Particle Measuring Systems
Paola has extensive professional experience over 14+ years supporting pharmaceutical companies in the application of regulatory requirements, with a specific focus on microbiological contamination control. She maintains this expertise through constant dialogue with Quality Officers, Production and Financial teams in the various industries she works with. She actively collaborates with the PMS Advisory Team on decontamination strategy using a Quality Risk Management approach and assists Pharma companies with the validation of sanitizing and decontaminating agents. Paola also regularly writes technical articles and participates as a speaker at national and international Pharma conferences.
