GMP for Medical Devices: EU versus FDA

The medical device industry has built-in quality systems which are based on Good Manufacturing Practices or GMPs. The regulatory bodies governing these systems are different in the EU and the US. In the USA, Center for Devices and Radiological Health (CDRG), FDA primarily regulates medical devices and FDA itself conducts all regulatory inspections. The US FDA has also laid down GMP compliance requirements for development, manufacturing, and distribution of medical devices in the Code of Federal Regulations: 21 CFR, Part 820.

Curriculum:

Introduction

Lesson 1: Differences Between EU and FDA GMP Requirements

• European main requirements
• FDA main requirements
• Difference
• Similarities

Lesson 2: GMP-Related Requirements of EN ISO 13485 : 2016

Lesson 3: FDA’s GMP Requirements in 21 CFR Part 820

Lesson 4: Design Controls of Medical Devices

• How to Implement Design Controls in Life Cycle Process

Lesson 5: Process validation

• FDA requirements for process validation
• What are clinical trials ?

Lesson 6: Complaint handling (Corrective and Preventive Action)

Glossary

Evaluation