Title: Module 4 Overview: Production and Process Controls
Course: PW-Course-Import-Test > Section: Module 4: Production and Process Controls

Module 4

In this module we will learn about 21 CFR 820.70 - Subpart G - Production and Process Controls. Production and Process Controls are included in the regulation to provide some routine, fundamental guidance to device manufacturers in order to consistently demonstrate/produce devices in accordance with design and process specifications. Without these controls, depending on the type of device that is manufactured, variability may be present in the manufacturing process. Processes can “drift” or change due to normal variation - and in some cases the process drift can create products that are nonconforming.

21 CFR 820 subpart G (Production and Process Controls) provides a framework for establishing a standardized control system methodology for medical device manufacturing.

Read

Read Production and Process Controls (P&PC) to learn more P&PC on the FDA Website.

Competency

After completing this module, you will be able to explain the purpose of production and process controls with the medical device industry.

Learning Objectives

- Cite the reasons behind why it is important to identify the status of manufacturing parts, components, assemblies and materials.
- Evaluate why Acceptance activities are required by the regulation.
- Identify the three (3) required types of acceptance activities as defined in 21 CFR 820.
- Assess the potential impact to product of failing to implement or follow established acceptance activities.