Faculty: Charles H. Paul | Code: SEM37661
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.
FDA GMP framework under 21 CFR Parts 210, 211 & 820
How FDA conducts inspections and gathers evidence
Understanding Form 483 observations and Warning Letters
Quality ownership and defined roles/responsibilities
Designing inspection-ready quality systems
Building defensible documentation practices
Creating a sustainable culture of compliance
This is Module 1 of Practitioner Course "GMP Master Class for Life Sciences".
You can either sign up only for this Module here.
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.