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Case Studies
in:
QbD: HOW TO FIT THE BUILDING BLOCKS
TOGETHER
September 23, 2009
WEBINAR
NOON - 1:30 pm EDT
The
life sciences industries are going through tremendous
changes that have been increased by the recent global
financial challenges. In order to help pharmaceutical and
biotech companies improve their operations, the FDA is
promoting the use of Quality-by-Design (QbD). Quality guru
Joe Juran proposed QbD in his book in 1992.
In the five years since the ICH outlined the
concept of design space in its Q8 guideline,
pharmaceutical companies – despite depending on innovation
for their livelihood – have been slow to adopt QbD. At the bottom of
that resistance there may lie something deeper:
fundamental misunderstandings about the nature of
QbD. In fact, in a recent survey of pharmaceutical
professionals, 40% of respondents identified “lack of
understanding of QbD” as their biggest problem with it.
Misunderstandings and misconceptions exist, some of which
have reached myth status.
This
Webinar focuses on developing understanding of what the
building blocks of QbD are and how the building blocks fit
together. Topics discussed include:
· Design
Space
· Process
Understanding
· Risk
Management
· Experimental
Strategies and Design of Experiments
· Process,
Product and Analytical Method Robustness
· Successful
Deployment and Getting Started
Using
case studies and examples typical misconceptions will be
cleared up and a holistic approach to QbD will be
presented.
Instructor: Ron Snee, MS, 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. He recently
authored two articles on QbD, has coauthored 2 books on
the tools of QbD and speaks regularly at conferences and
meetings on the subject.
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
200 papers in the fields of performance improvement,
quality, management, and statistics.
FEE:
$345 for one person.
Call for
special discounts for multiple participants at your
site.
610-399-4897
ECCWEB130
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