Ensuring Consistent Quality in Pharmaceutical Water for Injection (WFI) Systems
Water plays a vital role across pharmaceutical manufacturing. In this session we will discuss preventive maintenance, practical risk assessment, and routine monitoring of WFI systems.
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Water plays a vital role across pharmaceutical manufacturing. It is used as a component of fermentation media, a solvent in production, and a cornerstone of cleaning and rinsing procedures. Each application carries distinct quality requirements, so the water system must deliver consistently controlled attributes aligned to its intended use. Any microbial or particulate impurities can introduce direct or indirect contamination risks, potentially affecting multiple stages of the manufacturing process.
To safeguard product integrity and protect patients, disciplined preventive maintenance, practical risk assessment, and routine monitoring are essential across the system at every critical point of use. Together, these measures create a resilient, well-characterized water system that enables manufacturers to operate with confidence and maintain sustained control over their environments.
Key Learning Objectives:
- Understand how water quality can directly impact product safety and compliance
- Identify practical strategies to reduce contamination
- Build confidence in maintaining a resilient, compliant water system
Who should attend:
- QA/QC Personnel
- Project Managers
- Production Managers and Supervisors
- Compliance Officer
- Regulatory Affair Specialist
- Environmental Monitoring Specialist
- Project Engineer
- Technical Specialist
- Lab Personnel
- Microbiologist
Speakers
Irene Maccagli
Contamination Control Advisory Specialist
Irene Maccagli is a recognized expert in pharmaceutical contamination control and GMP-compliant cleanroom operations. With a strong background in quality assurance, laboratory validation, and cleanroom qualification, she has supported quality control and validation departments across the pharmaceutical and medical device industries. Irene specializes in regulatory compliance, internal audits, validation master planning, and laboratory method validation. At Particle Measuring Systems, she develops technical documentation and educational resources to help global manufacturers implement effective environmental monitoring and utility contamination control strategies. Her work supports data integrity, regulatory readiness, and contamination risk reduction in GMP-regulated cleanrooms.
