Audit Readiness Mastery – How to Prepare Your QA/QC Teams for CDSCO, WHO-GMP, and USFDA Inspections
Description
Audit Readiness Mastery is a comprehensive 10-module program designed to equip QA/QC and pharma professionals with the knowledge, practical skills, and confidence needed to successfully face CDSCO, WHO-GMP, and USFDA inspections.
This course provides a complete roadmap to understanding global regulatory expectations, strengthening documentation practices, and ensuring data integrity across operations. Through simple explanations, real-world examples, and practical tools, participants learn how to prepare for audits, manage deviations, implement effective CAPA, and build a strong, sustainable quality culture.
From handling remote/hybrid audits to managing crisis situations during inspections, the program builds readiness at every level. The course also includes case studies, best industry practices, and insights that help teams stay audit-ready at all times—not just during inspection seasons.
Whether you’re part of QA, QC, Production, Regulatory, or Compliance, this course empowers you to support your organization in achieving consistent GMP compliance and delivering quality with confidence.
Course Curriculum
Module 1: Understanding the Audit Landscape
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1.1 Understanding the Audit Landscape
08:31
Module 2: Top 10 Observations in Indian Pharma Inspections
Module 3: Documentation, SOPs & Logbooks – No Loose Ends
Module 4: Conducting Internal Mock Audits
Module 5: Role of QA During Inspections – Front Room, Back Room & Beyond
Module 6: Data Integrity Hotspots in QC & Manufacturing
Module 7: Handling Audit Observations – CAPA That Works
Module 8: Building a Sustainable Audit Culture – Beyond the Checklist
Module 9: Preparing for Remote & Hybrid Regulatory Audits
Module 10: Managing Regulatory Audits in Crisis Situations
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