GMP 101 and Inspection Readiness

Description

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.

Agenda:

• 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.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