FLEXLINE RF-ST: Quality by Design in Action
From equipment design to risk assessment: a joint Comecer and Particle Measuring Systems webinar on Environmental Monitoring excellence
Join experts from Comecer and Particle Measuring Systems (PMS) for an insightful discussion on the role of Quality by Design (QbD) in developing robust Environmental Monitoring (EM) strategies for pharmaceutical manufacturing.
Through the example of the FLEXLINE RF-ST filling machine, attendees will discover how equipment design can directly impact contamination control, particle monitoring effectiveness, and sampling decisions. By bringing together expertise in aseptic filling technologies and environmental monitoring solutions, this webinar offers a practical perspective on building monitoring programs that support product quality and process reliability.
A real-world Environmental Monitoring Risk Assessment (EMRA) case study will illustrate how risk-based methodologies can help identify critical monitoring locations and strengthen compliance with current regulatory requirements.
Registrations close on September 20.
Key Learning Objectives:
- Understand how Quality by Design (QbD) principles can be applied during equipment design to support contamination control and environmental monitoring strategies
- Learn how Environmental Monitoring Risk Assessment (EMRA) is used to identify critical sampling locations, define monitoring frequencies, and strengthen a Contamination Control Strategy (CCS)
- A real-world case study based on Comecer’s FLEXLINE RF-ST
Who should attend:
- Production manager
- Manufacturing Team
- QA/QC Specialist
- Auditors
- Validation Engineers
- Regulatory Officer
- Environmental Monitoring Specialist
- Process Engineer
- Commissioning Engineers
Speakers
Serena Steidl
EMEA Advisory Project Coordinator, Particle Measuring Systems
Serena is a microbiologist with a strong background in biotech and pharma manufacturing. She has supported QC and QA teams across multiple GMP-regulated facilities, with expertise in sterility assurance, risk assessment, and environmental monitoring. Her experience spans immuno-chemical, chemical, and microbiological laboratories, where she has led key initiatives by delivering practical solutions that align with global cGMP guidelines. At Particle Measuring Systems, she focuses on contamination control strategies that support cleanroom compliance.
Andrea Zanotto
Product Manager Aseptic Fill Finish at Comecer
Andrea Zanotto is a Product Manager for Aseptic Fill Finish at Comecer S.p.A.
