Contamination Prevention and Environmental Control

This course focuses on contamination risk, one of the fastest ways to trigger regulatory concern. It examines facility design, personnel behavior, environmental monitoring, and sanitation validation from an inspector’s perspective. Participants will understand how small procedural lapses translate into cross-contamination risk and why environmental data must tell a consistent story. The emphasis is practical — how to align cleanroom discipline, flows, and monitoring programs with GMP expectations under 21 CFR 211 Subpart C. The result is stronger contamination control and fewer inspection surprises.

Agenda:

• Cleanroom behavior and gowning discipline
• Personnel and material flows
• Cross-contamination prevention strategies
• Cleaning and sanitation validation
• Environmental monitoring programs
• Facility and HVAC considerations
• Inspection expectations for aseptic and controlled areas

This is Module 3 of Practitioner Course "GMP Master Class for Life Sciences".

You can either sign up only for this Module here.

Or the entire course → Here

Who This Training Is Designed For

• Quality Assurance Departments
• Quality Control Departments
• Manufacturing Departments
• Operations Departments
• Production Departments
• Regulatory Affairs Departments
• Validation Professionals
• Engineering Departments
• Compliance Specialists
• Training Managers
• Document Control Personnel

Course Director: Charles H. Paul

Charles H. Paul is the President of CHP Consulting LLC – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 25 years and has published numerous white papers on varies subject from project management and technical writing to regulatory compliance in the life sciences.  The firm works with both domestic and international clients designing solutions for complex training and documentation issues within the life sciences.