Devices

Production and Process Controls Learning Module

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 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.”

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome