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Customer Testimonials
Nice response to my questions and good suggestions for moving forward.
Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,
I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.
Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

 Speaker Profile


Dan OLeary
President, Ombu Enterprises

Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. 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; 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.
 Upcoming Webinars
Device Master Record & Device History Record
The FDA's Quality System Regulation (QSR) requires each device manufacturer to compile the specifications and procedures for a medical device. The manufacturer must also compile records of the production history of the device. These two sets of records (DMR & DHR) are complimentary.
Live  Tuesday, July 9, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$245.00
Process Validation for Medical Devices
Process validation is a powerful technique to help you find the point where your process should operate. In addition, it can help you find the limits of the process. These limits, applied to the process inputs define the parameter space that produces satisfactory process output.
Live  Wednesday, August 7, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$245.00
Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan's performance using the operating characteristic (OC) curve. Participants will gain a solid understanding of how the OC curve is built, how to use it, and how to identify some of the most important points on the curve, including the AQL and RQL points.
Live  Wednesday, August 28, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$245.00
...more
 Recorded Webinars
Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
This course provides the attendees with the tools needed to understand and implement acceptance sampling.
Recorded ,
$295.00
Risk Management for Medical Devices - ISO 14971
This course provides the attendees with an overview of ISO 14971:2007 and implementation tips for an effective system for managing risk.
Recorded ,
$295.00
A Unified Approach to Complaints, Servicing, and FDA Reporting
This course provides the attendees with the information to implement an effective system for managing and reporting adverse events.
Recorded ,
$295.00
Managing the Medical Device Supply Chain
In this seminar, you will learn both the requirements for managing suppliers and the reasons for these requirements.
Recorded ,
$295.00
...more


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