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FDA GMP Inspection and For Cause Audit Training for Combination Products

This course will help you prepare your firm for FDA inspections and Notified Body (NB) audits. Using an interactive, hands-on approach, you will practice applying new knowledge and skills to the process end-to-end. You will use an FDA preparedness checklist to ready your site for inspection. During the course, you will establish and practice inspection management techniques and learn to communicate effectively with investigators. Learners will role-play investigation situations, such as preparing subject matter experts (SMEs) for answering investigator questions, front-room / back-room methodology, and opening and closing the inspection. You will gain the knowledge and practice to respond to observations or findings appropriately.

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High Level Overview of This Training Class

SkillsLab Class ?

Class Content


Class Duration

3 Days

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person

Certification of Completion


Continuing Education Units (CEU)


* This class is only available privately to groups of six or more. We can deliver the training at your facility or virtually, Ask for details. 


Upcoming Classes

Upcoming FDA GMP Inspection and For Cause Audit Training for Combination Products


There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!


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Register 3 people, 4th attends free!


*This offer cannot be combined with any other promotional offer(s).

Course Overview

What We Cover in This FDA GMP Inspection and For Cause Audit Training Course

Course Overview
SkillsLab Class

Introduction to Combination Products

  • Combination product terminology, definitions, and examples
  • Primary mode of action (PMOA)
  • Regulatory overview of combination products: US FDA and EU
Exercise! Your Combination Product and Regulatory Pathway

Overview of Inspections and Notified Body Audits

  • Inspection methods
  • Systems approach for investigations
  • FDA inspectional approach for combination products
  • Types of inspections
    1. Pre-approval (PAI)
    2. Routine surveillance
    3. For cause
    4. Postmarket
  • Notified Body audits
Exercise! Using Inspection Insight

Prepare for the Inspection

  • Inspection policies, procedures
  • Inspection team roles and responsibilities
  • Inspection process
  • Inspection preparation checklist
  • Front-room / back-room methodology
  • Inspection process flow
  • Components of a successful inspection
Exercise! Opening Meeting and Inspection Route Walk-Through
Exercise! Form Your Inspection Team
Exercise! Communication, Management, and Method Role-Play

Managing the Inspection

  • Receiving the investigator and opening meeting
  • Pre-inspection walk-through
  • Responding to questions
  • Sampling, affidavits, and requests for records and confidential information
  • Daily debriefs and planning
  • Inspection conclusion: Closing meeting
Exercise! Test the Receiving Process and Conduct an Opening Meeting
Exercise! Apply Communication Best Practices
Exercise! Respond to Requests
Exercise! Conduct a Closing Meeting

Responding to the Inspection

  • Responding to a Form 483 or warning letter
  • Responding to NB findings
  • Enforcement actions
Exercise! Respond to a Warning Letter

Preparing for a Mock Inspection

  • Review success criteria
  • Front-room / back-room test
  • Tips from experienced inspection managers
Exercise! Test the Interview Process
Workshop! Dry Run of the Process
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to

Identify types of medical device and drug / biologic combination products

Set up logistics and processes for hosting external auditors or investigators

Prepare subject matter experts for answering investigator questions

Practice articulating processes and discuss how prior nonconformities (NCs) have been addressed

Demonstrate auditee behaviors required for successful inspections

Gain insight into investigator techniques to “identify the why”

Who Should Attend

Who Should Attend

Intended for combination product manufacturing professionals who have minimal experience in participating in an FDA inspection or Notified Body audit. This course is meant to familiarize participants with what to expect and to prepare them for a mock audit, in order to avoid disciplinary action.  
  • Management
  • Internal auditors
  • QA/QC personnel
  • Front and back room staff
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