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How to Prepare for FDA Inspections

This course is designed so that you will: 
This course will provide the latest FDA expectations for compliance with Drug and Device GMPs, attendees will learn how to prepare, manage and successfully complete an FDA inspection.

Upon completion of this two-day course, the participants will gain comprehensive insight into the FDA’s latest expectations when conducting investigations and how to audit effectively for compliance with those expectations in mind

  • Prepare for the FDA’s current inspection strategy: inspection level, scope and subsystems
  • Improve inspection behaviors, including answering questions, reviewing records and volunteering information
  • Incorporate the QSIT approach into internal auditing
  • Create a comparative QSIT and Pharma systems based inspection table’s with FDA requirements and company documentation
  • Analyze common inspection pitfalls and implement proven solutions
  • How to respond to a 483s and Warning Letters

Course Description

Personnel attending this interactive program will have an opportunity to learn how to prepare for an FDA inspection, what to expect during interaction with FDA officials and how to respond to FDA observations. Additionally this course is a good refresher for all personnel involved in the FDA inspection process and an opportunity to compare your internal audit system against what a leading internal audit expert believes is the best approach to implement.
The following are examples of some of the issues addressed during the course:

  • What your organization can do to prepare for the inspection
  • What type of documentation is required and what is the correct format
  • What information can the FDA request during an inspection
  • When can the FDA take action without issuing a Warning Letter
  • What does the FDA look for during inspections
  • What do the FDA's export regulations mean to your firm & How to respond to FDA actions

Who Should Attend

This program is designed to provide attendees with the tools and knowledge necessary to upgrade their inspectional quality system knowledge to current GMP levels. Those who are responsible for managing and hosting FDA Inspections will also benefit from this course.


Module 1: FDA Organization and Enforcement
FDA Strategy and Organization
The Law and Regulations Formal Enforcement
Tools Informal Enforcement Tools
Module 2: Latest FDA Issues and Initiatives
Top 5 Warning Letters
Top 10 Drug 483’s
Top 10 Device 483’s
FDA Initiatives and Changes
Module 3: Management Responsibility – Latest Expectations
Executive Vulnerability
Training Audits
Management Reviews
Corrective & Preventive Action (CAPA) - Latest Expectations
Module 4: Corrective & Preventive Action (CAPA) – Latest Expectations
New Definitions
Non-conformances Versus Deviations
Expected Elements Of CAPA System
Module 5: GMP Documents & Documentation Requirements
Types and Controls
Problem Areas
Change Control Problems
Quality Records Review
Module 6: Out Of Specification (OOS) – Latest Expectations
Laboratory Investigation
Production Investigation
Sample Warning Letters
Module 7: Part 11 Elec. Signature/Records – Latest Expectations
Current Focus
Warning Letter Issues
Module 8: Product Development & Design Control – Latest Expectations
Product Development Regulations
Most Frequent observations
Documentation Expectations
Module 9: QSIT and systems based inspections – Current FDA Inspection Approach
What QSIT Is
How QSIT Works
Six System Inspection Model: Drug Manufacturing Inspections
Quality Systems Approach to Pharmaceutical
Current Good Manufacturing Practice
Module 10: Complaint Handling – Why are complaints handling systems cited as a top observation?
Aspects Inspected
Records Requirements
Tracking and Trending
Module 11: FDA Inspection Do’s and Don’ts
Procedure For Inspection Accommodation
Records Readiness
Who To Include/Not Include
What To Say/Not To Say
Addressing a 483
Developing Initial Response
Timeliness Of Response
Module 12: Why Internal Audit Systems Fail
The Pass/Fail Criteria
Auditor Versus Verifier
Auditor Fear Factors
Questions & Wrap-Up
When delivered as an in-house program, this course is fully customizable to meet the specific needs of an organization.

*Before registering for any of our courses, read our Cancellation policy and  registration policies and procedures.
*All courses can be taught in Spanish