subject: Raps Pre-approved Webinar On fda Qsr Acceptance Activities From Globalcompliancepanel [print this page] 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.
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.
