Raps Pre-approved Webinar On fda Qsr Acceptance Activities From Globalcompliancepanel

Description:

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:

oreceiving

oin process

ofinal

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 FDAs intent as provided in the preamble to the regulations.

It explains the guidance offered in theFDAs 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:December 19, 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 Masters 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

oQuality Managers

oQuality Professionals

oProduction Managers

oProduction Supervisors

oManufacturing Engineers

oProduction Engineers

oDesign Engineers

oProcess Owners

oPurchasing Professionals

oInspection and test Managers

----------------------------------------------------------------------------------------------------------------

Duration: 90 minutes

-----------------------------------------------------------------------------------------------------------------

To enroll for this webinar, contact

webinars@globalcompliancepanel.com

Phone: 800-447-9407

by: GlobalCompliancePanel

POST COMMENT

human Behavior In Cleanrooms And Controlled Environments From Globalcompliancepanel Capture Global Market Through Custom Website Design Fort Lauderdale Platinum Buyer: Purchasing Platinum The Emerging Trend Useful Guidelines For Purchasing Led Light Fittings What You Should Find Out About Purchasing Clarks Privo Study In A Globally Reputed University For The Best Of Your Career A Guide To Holiday Cargo Shipping To Mexico Get Maximum Global Exposure Through Seo Services Of Omaha Accra Standing By As A Favorite Destination For Global Tourists A Guide To Holiday Cargo Shipping To Puerto Rico Global Traveling Community Hit Philippines To Explore It Help For You In Purchasing Electric Panels The Paradise Of Khartoum Waiting For Global Visitors