Scheduled On : Thursday, October 10, 2013 at 01:00 PM EDT Duration: 90 Minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1130

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Webiar Description:
Areas Covered in the Session :
Who Will Benefit:
Speaker Profile:
For device company Warning Letters in 2012, Acceptance Activities, 820.80, was the fourth most frequently cited QSR
section. The trend continues in 2013. Not only are acceptance activities important for themselves, they link to many other
QSR sections.
Acceptance activities can be hidden problems, waiting for an FDA Inspection to surface them. You don’t need to worry if
you implement a solid program. This webinar guides you through the five subsections of 820.80 acceptance activities and
explain how they integrate with other parts of QSR.
Level : Intermediate
To register for this webinar please visit our website www.compliancetrainings.com
Acceptance Activities in FDA QSR
Dan O'Leary, President, Ombu Enterprises, LLC, 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, focusing on logic and
number theory. His professional experience relates to quality, regulatory, reliability, and
operations management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality
Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in
Resource Management.
Thursday, October 10, 2013
Duration : 90 Minutes
10:00 AM PDT | 01:00 PM EDT
Speaker | Dan Oleary
Attendees of Acceptance Activities will:
> Develop an understanding of the parts of acceptance activities
> Learn how to document acceptance activities as part of the 820.20(d) quality plan
> Understand how to apply statistical techniques, especially sampling plans, to acceptance activities
> Understand the fundamental linkage between purchasing controls and receiving acceptance
> Understand how acceptance activities support the DMR and provide data for the DHR
To register for this webinar please visit our website www.compliancetrainings.com
This webinar is a must for professionals in the device industry, including:
> Quality Engineers
> Production Managers
> Production Supervisors
> Quality Assurance and Quality Control
> Quality Inspection and Test Managers
> Purchasing Managers
> Regulatory Affairs
> Supply Chain Specialists