LIVE WEBINAR

Aseptic Processing and Contamination Control Under EU GMP Annex 1

Practical Applications for Modern Sterile Operations

ABOUT THE COURSE

Contamination control decisions depend on interpreting operational signals, intervention risks, and monitoring evidence before they become confirmed sterility concerns. This session organizes contamination control practices, environmental monitoring interpretation, intervention management, and quality decision-making within modern sterile manufacturing operations under EU GMP Annex 1.

The session progresses from Annex 1 contamination control principles into practical operational situations involving interventions, monitoring results, investigations, and corrective actions. Throughout, the discussion connects regulatory expectations with day-to-day manufacturing decisions that support consistent sterility assurance and sustainable contamination control programs.

Designed for organizations responsible for sterile manufacturing, contamination control, environmental monitoring, validation, quality oversight, and ongoing operational performance.

KEY AREAS COVERED

Applying Contamination Control Strategy principles in practice
Environmental monitoring trends and early risk indicators
Managing aseptic interventions and contamination risks
Investigation and escalation of contamination events
Corrective actions supporting lasting contamination control
Evidence supporting sterility assurance under EU GMP Annex 1

Course Director

Meredith Crabtree

Meredith Crabtree brings more than 30 years of experience across pharmaceutical, medical device, blood, tissue, laboratory, and other regulated industries. Her work in manufacturing, packaging, labeling, regulatory assessments, recall support, and quality training provides practical insight into contamination control, operational oversight, and the implementation of regulatory expectations within sterile manufacturing environments.

FDB1613

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