CFR 820 2 Day

Delivering in-house training in Medical Devices- Quality Management Systems-CFR820 and ISO 13485

Call Rachel McLean +44(0)1292 671555

CFR 820 QS Regulation

Designed and developed for delegates who have a complete understanding of Quality Systems and wish to design, document, develop, improve and maintain their Quality Management System to meet CFR 820 Requirements and integrate with ISO13485

Day 1 Course Contents

Review of the Standard & Design Requirements

Regulatory Overview
General Provisions
Design Controls
- Planning & Risk Assessment Design Controls
- Design Validation
- Design History File
Acceptance Activities
Production & Process Control
Product Control
Monitoring & Feedback
Documents & Records
- Device Master record
- Device History Record
- Quality System Record

Call Rachel McLean on +44(0)1292 671555 or email rachel@gpb.ltd.uk to discuss your needs.

Day 2 Course Contents

Integrating with ISO 13485, Process Validation & QSIT

Integrating CFR 820 & ISO 13485 Requirements
Process Validation
- What Process Require to be validated?
- Models / Tools
- Procedures
- Records
- Process Changes
QSIT Inspection Model
- The Model
- Preparing for Inspections