> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Production and Process Controls Learning Module
- URL: https://www.fdaweb.com/production-and-process-controls-learning-module/
- Published: 2020-01-14T12:00:00.000Z
- Updated: 2026-09-14T15:58:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145838

A new *CDRH Learn* Webcast module, “Production and Process Controls, Part 2: Acceptance Activities, Handling, Storage, Distribution, and Installation,” reviews the purpose of the production and process controls subsystem and describes aspects of acceptance activities, handling, storage, distribution, and installation. Presented by CDRH Division of Industry and Consumer Education consumer safety officer **Vidya Gopal**, each [topic](http://fda.yorkcast.com/webcast/Play/a2350a316b774c918baa21230d36b6dd1d?ref=fdaweb.com) covers the regulatory requirements, implementation strategies, and then examples.

Gopal points out that the production and process controls subsystem is a key part of the quality system for medical device manufacturing. It helps companies ensure that they manufacture products that meet specifications and that they build the products they say they are going to build.

“Manufacturers need to develop, conduct, control, and monitor production processes,” she says. “They also need to validate or fully verify processes to ensure that a device conforms to its specifications. Manufacturers must also control the product and its environment throughout handling, storage, distribution, and installation.”