Monday, November 24, 2008

6 Free FDA QSR Design Controls Tutorials

Updated 8/10/2016:

You might also be interested in this blog post:
FDA Doubles Down on QbD (BioProcess Blog)

- -  original post follows below  - -

ODDS Company describes itself as an "educational and consulting company that deals with product and process improvements at all levels (from Executive Management to engineering support staff). ODDSCO is particularly useful to medical device manufacturer organizations that always must remain auditably compliant with FDA 21 CFR 820, the Quality System Regulation."

The ODDSCO website offers 6 free tutorials for this reason, "unless basic knowledge of any claimed area of expertise is understood, the value of offered consulting and training services will not be apparent and likelihood of sales is small. But, if the free basic training is perceived as useful and indicative of consultant's knowledge, that likelihood improves. In other words, when equipped with the basic knowledge, a visitor whose organization desires to virtually automate effective QSR Design Controls compliant medical devices development with minimal resources and schedule impact could become a highly qualified customer or client."

The Six (6) Free Tutorials (go to the ODDSCO site for amplified descriptions):
1. Automating FDA QSR Design Controls Compliance
2. Integrated Product/Process Team, Concurrent Engineering, and Systems Engineering
3. The Continuous Improvement Process (CIP) and Total Quality Management (TQM)
4. Knowledge Support Systems (KSS) and Tools
5. An IPPT Supporting Decision Process
6. Project Risk Assessment

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