THE FIRST 15 THINGS I WOULD REQUEST IF I WALKED INTO YOUR FACILITY AS AN FDA INVESTIGATOR — PART I

THE FIRST 15 THINGS I WOULD REQUEST IF I WALKED INTO YOUR FACILITY AS AN FDA INVESTIGATOR — PART I

The requests may sound routine. They aren’t.

What could an FDA Investigator really learn from a product list or an organizational chart?

Potentially far more than your company realizes.

In Part I of this revealing new series, former FDA Investigator DeVaughn Edwards explains how seemingly ordinary document requests can become the starting point for a much deeper investigation into process validation, product risk, Quality Unit independence, organizational culture, resource limitations, management influence and the reliability of the information being presented to FDA.

This is not another generic FDA inspection checklist.

DeVaughn takes you behind the request and explains what an experienced Investigator may actually be thinking, what connections may be developing and what could cause the inspection to move in an entirely unexpected direction.

PART I EXAMINES TWO DECEPTIVELY SIMPLE REQUESTS:

1. “Please provide me with a list of all products currently manufactured at this facility.”
2. “Please provide me with your current organizational chart.”

For each request, you will learn:

• What the Investigator initially asks for

• What the Investigator may really be evaluating

• What responses could trigger deeper scrutiny

• How records from different systems may become connected

• How an Investigator tests the reliability of management’s statements

• The “Investigator’s Secret Sauce” behind the request

You will see how a product list can lead to process validation, complaints, deviations, change controls, cleaning procedures, laboratory records and CAPAs. You will also learn how an organizational chart can lead an Investigator into questions involving Quality independence, staffing, management pressure, escalation practices and fear within the organization.

The most valuable lesson is not simply knowing which documents an Investigator may request. It is understanding how the Investigator uses those documents to decide where to go next.

WHO SHOULD READ THIS?

This publication is especially valuable for:

• Quality Assurance and Quality Control professionals

• Manufacturing and Operations leaders

• Regulatory Affairs professionals

• Site Heads and senior pharmaceutical executives

• Inspection readiness teams

• Consultants, auditors and GMP trainers

• FDA Investigators and other regulatory professionals

• Anyone responsible for preparing a facility for an FDA inspection

ABOUT THE AUTHOR

DeVaughn Edwards spent 14 years as an FDA Investigator conducting domestic and international inspections. He subsequently spent more than a decade in pharmaceutical Quality and Compliance leadership, where he experienced FDA inspections from the industry side of the table.

Today, through FD-AID, LLC, he helps pharmaceutical companies prepare for FDA inspections, identify compliance vulnerabilities and understand what an experienced Investigator may discover before FDA walks through the door.

FORMAT: Professionally designed downloadable PDF

SERIES: The First 15 Things — Part I

ACCESS: Immediate download following purchase

FDA inspection readiness requires more than having the requested documents available.

You need to understand what those documents may tell the Investigator.