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Recorded WebinarNew

Contamination Prevention and Environmental Control

Build inspection-ready contamination control systems — cover cleanroom behavior, environmental monitoring, sanitation validation, and GMP expectations under 21 CFR 211.

4.8(0 reviews)
1.5 hours
Charles H. Paul

Instructor

Charles H. Paul

President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence

What You'll Learn

Cleanroom behavior, gowning discipline, and personnel flows
Personnel and material flow strategies to prevent cross-contamination
Cleaning and sanitation validation requirements
Environmental monitoring programs aligned with GMP expectations
Facility and HVAC considerations for contamination control
FDA inspection expectations for aseptic and controlled areas

About This Event

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. This is Module 3 of the Practitioner Course "GMP Master Class for Life Sciences." Code: SEM37663

Curriculum

Cleanroom Behavior, Gowning Discipline, and Personnel Flows
12 min
Cross-Contamination Prevention Strategies
12 min
Cleaning and Sanitation Validation
12 min

Requirements

  • QA, QC, Manufacturing, and Engineering professionals in pharmaceutical or biotech environments
  • Applicable to validation professionals, compliance specialists, and training managers

Meet Your Instructor

Charles H. Paul

Charles H. Paul

President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence

Charles H. Paul is President of CHP Consulting LLC, a regulatory compliance, operational excellence, training, and technical documentation consulting firm supporting pharmaceutical, biotechnology, medical device, and advanced therapy organizations worldwide. With more than 30 years of experience in regulated manufacturing environments, Charles specializes in helping organizations build sustainable quality systems that support compliance, operational performance, workforce effectiveness, and inspection readiness. His experience includes GMP quality systems, manufacturing operations, technical training development, process validation, deviation management, CAPA systems, operational excellence, documentation systems, and regulatory inspection preparation. Charles has supported organizations implementing new technologies, expanding manufacturing operations, establishing quality infrastructures, and preparing for complex regulatory inspections. He is a recognized author, speaker, and consultant who has delivered numerous webinars and seminars on GMP compliance, quality systems, human performance improvement, technical documentation, inspection readiness, and operational excellence throughout the life sciences industry.

30+ Years Regulatory ConsultingAdvanced Therapy GMP SpecialistSOP & Documentation ExpertLife Sciences Trainer & Author
Quantity
1

Recording – 1 Viewer

$398.00
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Certificate of completion

Event Details

Format

Recorded Webinar

Duration

1.5 hours

Certificate

Included

Access

Lifetime

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