GMP 101 and Inspection Readiness
Establish the mindset for modern GMP compliance — understand how FDA inspects, why documentation gaps become findings, and how to build inspection-ready systems.
Instructor
Charles H. Paul
President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence
What You'll Learn
About the event
About this event
This course establishes the mindset shift required for modern GMP compliance. It explains how FDA interprets 21 CFR 210, 211, and 820 during inspections and how evidence is gathered to support observations. Participants learn why minor documentation gaps become major findings and how to design systems that demonstrate control rather than merely claim it.
The focus is on ownership, accountability, and inspection psychology. By understanding how investigators evaluate systems, teams can proactively strengthen documentation, clarify roles, and embed readiness into routine operations instead of scrambling before audits.
This is Module 1 of the Practitioner Course "GMP Master Class for Life Sciences."
Code: SEM37661
Curriculum
Requirements
- QA, QC, Manufacturing, Regulatory Affairs, or Compliance professionals in life sciences
- Applicable to validation professionals, engineers, training managers, and document control personnel
Meet Your Instructor
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.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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