The Ultimate Clinical Audit Tool
A downloadable, professionally developed audit tool created by a former FDA Investigator and pharmaceutical industry executive. This comprehensive guide is designed to help Quality, Regulatory, and Compliance professionals conduct effective GMP audits—targeting the same areas the FDA focuses on. Whether you're preparing for an inspection, conducting a mock audit, or evaluating suppliers, this tool provides the structure, questions, and insight needed to spot gaps before the regulators do.
Includes:
✔ Step-by-step audit framework
✔ Targeted questions based on 21 CFR 211 and FDA inspection practices
✔ Common deficiencies observed by the FDA
✔ Sections for your own notes and findings
✔ Fillable fields for digital use or print-and-write convenience
Perfect for:
🔹 Internal Quality Audits
🔹 Mock FDA Inspections
🔹 Supplier Qualification
🔹 Inspection Readiness Projects
A professional GMP audit tool developed by multiple former FDA Investigators to help Quality and Compliance teams identify deficiencies, prepare for inspections, and conduct effective internal or supplier audits.