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FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD
Date:8/14/2014

Falls Church, VA (PRWEB) August 14, 2014

Innovative Process Validation Strategies for Medical Devices:
Proving Your Processes and Documentation to the FDA
**Presented by Ombu Enterprises and FDAnews**
Aug. 26-27, 2014 – Bethesda, MD
http://www.fdanews.com/ProcessValidationConference

The quality plan has been reviewed and it’s time to focus on production processes. However, the review raises a question about which processes need process validation. But not to worry, because there is the new FDA guidance document.

The plan is to download, read it, and follow its advice. The CDRH search engine shows there is no device guidance document!

The “FDA guidance document” is for pharmaceuticals, biologics, and veterinary medicine. FDA does not have a guidance document for devices.

A colleague suggests brushing up on statistics, because process validation includes statistical techniques. The GHTF guidance document is an option, but it looks complex.

It is necessary to understand the issues from the regulatory requirements to the applications that would help build the system.

Hands-on training is needed. Introducing, Innovative Process Validation Strategies for Medical Devices Workshop — Proving Your Processes and Documentation to the FDA. This interactive workshop presented by Ombu Enterprises and FDAnews is being held Aug. 26-27, 2014 at the Marriott Bethesda North Hotel and Conference Center in Bethesda, MD.

Attendees will learn:

  • The concepts of process validation including a distinction between product verification and process validation
  • The require
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