← Back to QA Courses

FDA Testing
Quality Assurance and Testing in FDA–Regulated Environment
(40 hours)

1. Course Introduction

  • Course Overview

  • History of FDA

  • FDA Regulation Good Manufacturing Practice (GMP)

  • Design Control Regulation (CFR)

  • Software (SW) Regulation/Scope

2. Design and Development Planning-Part 1

  • SW Life Cycle (SLC) Model

  • Project Plan

  • Quality Assurance (QA) Plan

  • Risk Management Plan

  • Requirements Management (RM) Plan

  • Configuration Management (CM) Plan

3. Design and Development Planning-Part 2

  • Integration Plan

  • Verification Validation and Test (VV&T) Plan

  • SW Problem Resolution (SPR) Plan

  • Transfer Plan

  • Operations Plan

  • Maintenance Plan

  • Project History File (PHF) Plan

4. Design Review/Documentation

  • Review Procedure

  • Review Documentation

  • Project History File (PHF) Maintenance

  • Configuration Management

5. Risk Management

  • Risk Tools-ISO 14971

  • Hazard Analysis

  • Risk Evaluation

  • Risk Requirements

6. Design Input & Output

  • Design Requirements (System through Software)

  • Interface Requirements

  • SW Training/Procedures

  • Code Guidelines

  • Code Evaluations

  • Interface Analysis

  • Code Testing

7. Design Verification and Validation

  • Input vs. Output

  • Code Traceability

  • Code Review

  • Static Testing

  • Dynamic Testing

  • Interface Testing

  • Intended Use Testing

  • Validation Test Scripts

8. Design Transfer/Change

  • Installation

  • Documentation

  • Final Test

  • Mini SLC

  • Validation Regression Testing

9. Part 11 Requirements

  • Electronic Records

  • Electronic Signatures

  • Data Retention

  • Audit Trail

  • Legacy Systems

10. Special Software

  • Medical Device SW

  • COTS SW

  • Programmable Logic Controller (PLC) SW

  • Spreadsheets

  • Statistical SW

  • SW Development Tools

← Back to QA Courses

Home | About ACT | Admissions | Programs | Schedule
Free Training | Special Events | Contact / Map