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Statistical Techniques for Medical Device Manufacturers |
By - Dan O'Leary, President
at Ombu Enterprises, LLC on
Location: San Francisco, CA
The seminar starts with an
understanding of the regulations through a variety of sources. Ex: QSR, ISO
13485:2003, and ISO 13485:2016. Each application of statistical techniques starts
with the regulatory requirements and is augmented by the preamble, where FDA
addressed the comments it received on the proposed QSR. FDA published an
extensive manual to help manufacturers implement the regulations. The seminar
analyzes the objectives in the Quality System Inspection Technique (QSIT), the
Medical Device Single Audit Program (MDSAP) and then turns to Warning Letters
to help understand the methods of regulators.
In addition to statistical
methodology, as part of CA & PA information, is required to identity
recurring quality problems based on device manufacturers analysis. A similar
requirement applies to servicing analysis. The requirement for process
validation with a "high degree of assurance" is a requirement for
process capability and product characteristics, i.e., a statistical technique.
Upon course completion
participants will be able to:
- Learn the sections of FDA QSR that require statistical techniques.
- Understand how to apply the FDA tools to develop a clear understanding of the requirements.
·* Regulation
·* Preamble
·* Small Entity Compliance Guide
·* QSIT
·* Warning Letters
- Understand the set of statistical techniques in ISO/TR 10017
- Learn how to implement and apply the ISO/TR 10017 statistical techniques.
Register yourself for this
brainstorming session Now- Statistical Techniques for Medical DeviceManufacturers
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