RI 102 — 5 C’s to Respond to an FDA 483 (one half day, virtual)
Monday, 15 September 2025, 10:00 AM - 2:30 PM EDT
Registration Rates
- By 27 August 2025: Member $400, Non-member $530, University/Government $290*, Student/Outreach Members $185
- After 27 August 2025: Member $465, Non-member $595, University/Government $355*, Student/Outreach Members $185
Register Online
RQAP re-registration units: 4 GCP | GLP
Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.
Presenter(s)
Barb Munch, Ed Armstrong, Dawn Niccum, David Glasgow - FDA
Description
The 5 C’s course (Clear, Concise, Compelling, Complete, Compliant) was developed to help industry know best practices in how to respond to an FDA Form 483 and to reduce the likelihood of receiving a Warning Letter. Instructors will review the FDA Investigations Operations Manual (IOM) that discusses FDA investigator actions for GCP, GLP, and GMP establishment inspections. The IOM directs FDA investigators how to conduct and report inspections, including authority to enter, inspectional procedures, and reporting. Differences and similarities between GCP, GLP, and GMP when preparing for and hosting an FDA inspection will be discussed. Real-life examples of compliance issues will be presented, as well as a variety of scenarios with class participation with ways to respond, and ways not to respond, to an FDA Form 483. Content in this class is applicable to GCP, GLP, and GMP regulations; anyone working in any of these regulations will find the course valuable. We will explain how to receive an FDA Form 483, and how to respond using the 'Pittman 5 C's' to reduce the likelihood that incomplete responses could lead to a Warning Letter. For those who claim GLP compliance, this course information builds on GLP 105: Introduction to FDA GLP Bioresearch Monitoring Compliance Program; but it is not necessary to attend GLP 105 in preparation for this course.
Objectives
At the end of the course, participants shall be able to:
- Explain what to do when FDA identifies significant objectionable conditions and how to receive an FDA Form 483
- Describe the FDA’s expectations regarding FDA Form 483 responses using the 5 C’s
- Identify and prevent incomplete or unclear FDA Form 483 responses that could lead to a Warning Letter or Untitled Letter
- Identify relevant records that a firm should provide with their FDA Form 483 responses
- Develop internal processes and training to generate FDA Form 483 responses that meet all 5 C’s
Target Audience
GCP, GLP, and GMP QA personnel, Study Directors, Test Facility Management. Years of experience is irrelevant.
Agenda
- How not to respond
- Why was this class developed?
- FDA 483 myths
- FDA Investigations Operations Manual (IOM)
- Oh no, they found something!
- 5 C’s – Clear, Concise, Compelling, Complete,
Compliant
- Oh no, there’s a Warning Letter!
- Frequent FDA 483 topics
- FDA 483 real life examples
- Scenarios repeated, better ways to respond
- FDA references
- Class exercises #1 and #2
Level
Mixed-Level Audience: There is content for new folks as well as those who are experienced.