FDA cGMP Refresher Training Course Online

Program Overview

This refresher course focuses on critical updates, high-risk areas, common inspection findings, and advanced application of cGMP principles in day-to-day operations. Rather than re-teaching basic concepts, this program reinforces essential knowledge while introducing new regulatory expectations and industry best practices.

The course emphasizes:

A risk-based approach to decision-making
Practical implementation of data integrity principles
Lessons learned from recent FDA inspections and warning letters
Application of cGMP principles to real-world scenarios

Content is based on the current requirements of 21 CFR Part 210 and 21 CFR Part 211, along with relevant FDA guidance documents and industry best practices.

Target Audience

This course is intended for all personnel who have already completed foundational cGMP training and are actively working in FDA-regulated environments. The content is particularly relevant for:

Audience Group	Relevance
Production and Manufacturing Staff	Execute processes and need to understand how their actions impact product quality and regulatory compliance
Quality Assurance and Quality Control Personnel	Review documentation, perform testing, and make quality decisions that require up-to-date regulatory knowledge
Warehouse and Logistics Staff	Handle materials and products, maintaining the supply chain and preventing mix-ups
Maintenance and Engineering Teams	Responsible for equipment, utilities, and facility systems that must operate within validated parameters
Supervisors and Department Heads	Lead teams and must ensure their areas maintain cGMP compliance and address inspection findings

Prerequisites

Before starting this refresher course, you should have:

Successfully completed a foundational cGMP training program (minimum 12 hours of instruction)
Working knowledge of cGMP principles, terminology, and the basic structure of 21 CFR Parts 210 and 211
At least 6 months of experience working in a cGMP-regulated environment
Ability to read and understand technical documentation in English

How to Use This Program

Read each module thoroughly, from start to finish
Pay attention to key points highlighted throughout the text
Complete the self-assessment questions at the end of each module
Review incorrect answers and revisit the relevant content
Complete all modules before attempting the final assessment

Certification Requirements

To successfully complete this training program and receive certification, you must:

Requirement	Details
Module Assessments	Achieve a minimum score of 80% on all module assessments
Final Examination	Complete the comprehensive final examination with a score of 80% or higher
Completion	Complete all modules and assessments

Certificate of Completion

Upon successful completion of all module assessments and the final examination, you will receive a Certificate of Completion for the cGMP Refresher Course.

Certificate Details:

Participant’s full name Training program title and date of completion
Modules completed and average score achieved
Unique certificate number for verification purposes

Curriculum

10 Sections
9 Lessons
Lifetime

Expand all sectionsCollapse all sections

Module 1
2
- 1.1
  Foundations of cGMP – History, Purpose, and Regulatory Framework Refresher
- 1.2
  Questionnaire
  5 Questions
Module 2
2
- 2.1
  Organization, Personnel, and the Quality Control Unit Refresher
- 2.2
  Questionnaire
  5 Questions
Module 3
2
- 3.1
  Buildings and Facilities Refresher
- 3.2
  Questionnaire
  5 Questions
Module 4
2
- 4.1
  Equipment Refresher
- 4.2
  Questionnaire
  5 Questions
Module 5
2
- 5.1
  Control of Components and Drug Product Containers and Closures Refresher
- 5.2
  Questionnaire
  5 Questions
Module 6
2
- 6.1
  Production and Process Controls Refresher
- 6.2
  Questionnaire
  5 Questions
Module 7
2
- 7.1
  Packaging, Labeling, and Holding/Distribution Refresher
- 7.2
  Questionnaire
  5 Questions
Module 8
2
- 8.1
  Laboratory Controls, Stability, and Records Refresher
- 8.2
  Questionnaire
  5 Questions
Module 9
2
- 9.1
  Returned and Salvaged Drug Products Refresher
- 9.2
  Questionnaire
  5 Questions
Final Examination
The final examination consists of 20 questions covering all modules of this refresher course. You must achieve a score of 80% or higher (16 out of 20 correct answers) to successfully complete the program and receive certification.
1
- 10.1
  Questionnaire
  20 Questions

Instructor

GxP Trainings

145 Students

71 Courses

We provide training programs designed to help you meet quality and compliance standards. Our courses cover GMP, GLP, GCP, GEP, GDP, and Quality Assurance.

$149.00

Student:

1 Student

Lesson:

9 Lessons

Duration: Lifetime

Quiz:

10 Quizzes

Level: All levels

Certificate on completion

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FDA cGMP Refresher Training