Essential GMP Skills: Environmental Monitoring & Microbiological Awareness
This one-day classroom and laboratory-based course provides hands-on training for GMP production staff. It ensures participants are able to maintain aseptic conditions, follow environmental monitoring practices, meet regulatory requirements, and support safe pharmaceutical and biopharmaceutical manufacturing processes.
Learning objectives:
- Explain and apply fundamental GMP principles to meet regulatory requirements.
- Understand and practice Environmental Monitoring methods to monitor and control the manufacturing environment.
- Learn microbiology basics—organism types, growth conditions, risks, and impact on product quality.
- Understand cleanroom requirements, including gowning and hygiene.
- Become familiar with microbiological and particulate sampling and testing techniques.
- Identify and assess risks of microbiological contamination.
- Understand the importance of accurate documentation for compliance and traceability.
- Learn how to respond deviations and to implement corrective and preventive actions.
- Apply regulatory guidelines for environmental monitoring and microbiology in GMP settings.
Who should attend:
Those new to regulated industries—biotherapeutics, ATMPs and pharmaceuticals—as well as staff in Manufacturing, QC, QA, cleanroom operations, validation, compliance, engineering and maintenance seeking stronger EM and microbiology awareness.