INTRODUCTION

The US FDA 21 CFR Part 820 – Quality System Regulation was developed and published to regulate and monitor medical devices and their life-cycle activities. The US FDA 21 CFR Part 820 outlines the current good manufacturing practice (cGMP) guidelines for the manufacturers and other relevant organizations to ensure the efficacy and safety of the medical devices.

Compliance with the regulatory requirements is crucial to ensure constant device supply and benefits to the users. A thorough understanding of the regulatory requirements is necessary to ensure effective implementation and continuous compliance. It will also elevate the confidence level in the manufacturers to prepare and host periodic FDA inspections.

COURSE OBJECTIVES

This course aims to help delegates to understand the US FDA 21 CFR Part 820 requirements and get themselves ready for the FDA inspection. The consultant will also share practical examples to help delegates to understand the content better and guide them on effective implementation of the requirements.

The course content outlined is to provide delegates with:

• Understanding on the role and responsibilities of the US Food and Drug Administration (FDA)
• Knowledge and interpretation of the 21 CFR Part 820 requirements
• Simple practical implementation examples
• Readiness for the US FDA inspection

COURSE OUTLINE

• Opening & Introduction
• The US Food and Drug Administration
• The Federal Food, Drug, and Cosmetic Act (FD&C Act)
• The Code of Federal Regulations
• 21 CFR Part 820 (Subpart A-O)
• FDA Inspection – The Expectation and Preparation
• The FDA inspection outcomes
• Summary

COURSE BENEFITS

Upon completion of this training, delegates will: –

1. Have a good understanding of the US FDA CFR Part 820 requirements
2. Be able to put the requirements into effective implementation
3. Understand the FDA inspection process and the expectation

TARGET AUDIENCE

This programme is designed for ALL functions and levels of an organization who need to gain understanding of the FDA 21 CFR Part 820 requirements, especially organizations that has embarked on the journey and plan to expand their market reach to the United States of America.  This programme is particularly useful to those managing the quality management system, process owners and internal auditors.