GMP for Medical Devices and FDA 21 CFR PART 820

All common medical procedures require medical devices and they are used by laypersons at home and by healthcare professionals in medical facilities. From palliative care to diagnosis, prevention, and screening, medical devices can do it all. It is therefore vital that they comply with the highest standards of quality.

This online training also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services

Curriculum:

Introduction

Lesson 1: Design Controls of Medical Devices

• What does design control refer to ?
• What is the process for applying design controls to medical devices ?

Lesson 2: Document Controls of Medical Devices

• Document approval and distribution

Lesson 3: Purchasing Controls of Medical Devices

• Evaluation of Suppliers, Contractors, and Consultants
• Extent of control
• Purchasing Data

Lesson 4: Identification and Traceability

Lesson 5: Production and Process Controls

Lesson 6: Acceptance Activities

Lesson 7: Requirements for Nonconforming Product

Lesson 8: Corrective and Preventive Action

Lesson 9: Labeling and Packaging Controls of Medical Devices

Lesson 10: Handling, Storage, Distribution, and Installation of Medical Devices

Lesson 11: Records

• Device History Record (DHR)
• Device Master Record (DMR)
• Device History Record (DHR)

Lesson 12: Servicing and Statistical Techniques

Glossary

Evaluation