RAPS Pre-Approved Webinar on "FDA QSR Acceptance Activities" From GlobalCompliancePanel

Fremont, California (PressExposure) March 23, 2013 -- Description:

This webinar is about regulations found in FDA QSR manual and how they need to be implemented.

FDA's Quality system Regulation (QSR) sets requirements for acceptance activities related to medical device manufacture.

These requirements cover three acceptance areas:

o receiving
o in process
o final

These are discussed in this webinar. Another unique aspect of the QSR is that it has specific requirements for procedures and minimum requirements for record keeping. This webinar takes a look at the regulations and discusses the FDA's intent as provided in the preamble to the regulations.

It explains the guidance offered in theFDA's QSR Manual. This guidance helps manufacturers implement the regulations using explanation and sample procedures and forms.

In addition, the FDA has recommended, manufacturersobtaina copy of the Warning Letters to help them come into full compliance. This session will discuss how to go about this. It will also examine the rationale on which FDA issues Warning Letters. This session will offer advice on how to avoid common pitfalls that could invite Warning Letters.

When:April 3, 10:00 AM PDT | 01:00 PM EDT

By whom:

Dan OLeary is the President of Ombu Enterprises, LLC. Started in late 2008, Ombu is a company that offers small manufacturing companies training and execution in operational excellence with a focus on analytical skills and a systems approach to operations management. Ombu handles issues relating to Operations and Quality. It offers education, training and execution in operational excellence.

Dan has more than 30 years' experience in Quality, Operations and Program Management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Master's Degree in Mathematics from University of Maine; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt, and is certified by APICS in Resource Management.

Prior to his association with Ombu, Dan has held many positions, including being Director, Program Office at Quest Diagnostics, Inc., Vice President of Operations at S&S Bioscience, Inc. and Business Process Executive - Manufacturing at Marconi Medical Systems.

For whom:

The webinar will benefit

o Quality Managers
o Quality Professionals
o Production Managers
o Production Supervisors
o Manufacturing Engineers
o Production Engineers
o Design Engineers
o Process Owners
o Purchasing Professionals
o Inspection and test Managers

Duration: 90 minutes

To enroll for this webinar, contact


Phone: 800-447-9407

About GlobalCompliancePanel

GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.

GlobalCompliancePanel offers a broad range of channels for broadcasting and exchange of information through web based training, web alerts & discussion forums.

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Press Release Source: http://PressExposure.com/PR/GlobalCompliancePanel.html

Press Release Submitted On: March 22, 2013 at 5:49 am
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