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Food Safety Online Training
Recorded Webinars collaborated with Foodseminarsinternational
Quality by Design
(Webinar length:  1h 15m)


The Pharmaceutical and Biotech industries are going through tremendous changes that have
been increased by the recent global financial challenges.  The FDA is promoting the use of
Quality-by-Design (QbD) as an approach for helping companies speed up development and
improve their operations.  When one is working to implement QbD, deciding what data to
collect, when to collect it, and how much data to collect can be problematic.  Examining the
building blocks of QbD provides valuable insight to strategies needed to guide the data
collection process. Creating and using strategies based on an assessment of the
experimental environment enables the collection of the right data in the right amount at the
right time. This session discusses how to develop appropriate strategies and the tools
needed to implement the strategies.  The concepts and methods involved will be introduced
and illustrated with pharmaceutical and biotech case studies and examples.

What an Attendee will Learn:

Building blocks of QbD—Guiding principles, tips, and traps
Limitations of the One-Factor-at-a-Time approach to experimentation
A strategy of experimentation that reduces the risk of missing important variables
Diagnosing the experimental environment to identify the most effective experimental strategy
Success factors that enable effective experimentation
How to collect the right data in the right amount at the right time
How to create successful experimental strategies for test programs

Presenter:      Ronald D. Snee, PhD

Ron Snee is Founder and President of Snee Associates, a firm dedicated to the successful
implementation of process and organizational improvement initiatives. He provides guidance
to senior executives in their pursuit of improved business performance using Quality by
Design, Lean Six Sigma and other improvement approaches that produce bottom line results.
Prior to his consulting career he spent 24 years at the DuPont Company in a variety of
assignments including pharmaceuticals. He has been developing and applying Strategy of
Experimentation and QbD methodologies for more than 30 years. His recent application and
research on QbD has produced eight articles on use of QbD in Pharma and Biotech. He has
also coauthored 2 books on the methods and tools of QbD and speaks regularly at
conferences and meetings on the subject. He teaches QbD and related methodologies as an
Adjunct Professor at Temple University School of Pharmacy.

Ron received his BA from Washington and Jefferson College and MS and PhD degrees from
Rutgers University.  He is an academician in the International Academy for Quality and Fellow
of the American Society of Quality, American Statistical Association, and American
Association for the Advancement of Science.  He has been awarded ASQ’s Shewhart and
Grant Medals, and ASA’s Deming Lecture Award as well as numerous other awards and
honors.  He is a frequent speaker and has published 4 books and more than 225 papers in
the fields of performance improvement, quality, management, and statistics. He is a past
recipient of the Institute of Validation Technology Speaker of the Year Award.

Webinar Price ($289)
Click here to buy it

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