Case Studies in:
QbD: HOW TO FIT THE BUILDING BLOCKS TOGETHER
August 17, 2010 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:
$365 for one person.
$700 2-5 people
$999 6-10 people
.
610-399-4897
ECCWEB197
|
