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Webinar On Method Validation:

Utilizing Quality by Design and Risk in
Implementation
Ronald D. Snee

Presented By Dr.

Scheduled On : Wednesday, April 29, 2015 at

13:00 Hrs EDT

Hosting By
Compliance
Trainings

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Method Validation: Utilizing Quality by Design (QbD)

and Risk in Implementation
Product
Product Id
Id
Category
Category
Scheduled
Scheduled On
On
Duration
Duration

FDB1431
FDB1431
Food, Drugs
Drugs &
Food,
& Biologics
Biologics
Wednesday, April
April 29,
Wednesday,
29, 2015
2015 at
at 13:00
13:00 Hrs
Hrs
60 Minutes
Minutes
60

Speaker
Speaker

Dr.
Dr. Ronald
Ronald D.
D. Snee
Snee

Login at
https://compliancetrainings.com/siteengine/Login.aspx
Webinar Description:

Pharmaceutical industry is experiencing a growing need to improve

performance driven by global competition and the increasing impact
of information technology. FDAs Process Validation Guidance calls for
continued process verification which applies to both manufacturing
and measurement processes. How to go about this improvement in a
systematic, focused and sustainable manner is the question.
Fortunately a world-class body of improvement technology exists
known as Quality by Design (QbD); a science and data-based
approach that builds quality into products and processes during
development, validation and operations.
A characteristic of good science is good data. Quality data are
arguably more important today than ever before. Using a series of
case studies and examples it will be shown how QbD can be
integrated into a holistic approach that can be used to effectively
design and improve laboratory processes enabling prompt, successful
method validation. Methods discussed in this session include
assessment of method design, repeatability and reproducibility,
improving method robustness and measurement process control.

Methods for assessing that amount of product variation that can be

attributed to the manufacturing process, sampling procedures and
test method are also presented. The concepts and methods involved
will be introduced and illustrated with pharmaceutical and biotech
case studies and examples.
Areas Covered in the Session :

Participants in the webinar will learn how to improve test method

performance by:
Rapid design and development of test methods using statistical
design of experiments
Improving measurement quality using Gage Repeatability and
Reproducibility studies
Developing measurement systems that are robust to variations in
method use
Controlling measurement variation by using control samples and
statistical process control techniques
Identifying how much of the total variation is due to the
manufacturing process, the sampling procedure and the test
method
Who Will Benefit :

Executives and Managers engaged in Pharmaceutical and Biotech

Research and Development
Quality Assurance Personnel
Regulatory Affairs Professionals
Test Method Development and Validation Personnel
Quality Engineers
Process and Manufacturing Engineers
Research and Development Scientists
Operations Excellence Professionals
Biologists and Microbiologists
Chemists and Chemical Engineers
Anyone with a desire to learn the fundamentals of methodical
performance improvement

Speaker Profile

Ronald D. Snee, PhD, 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 QbD methodologies for more than 30 years. His recent
application and research on QbD has produced more than ten
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 and Rutgers University
Pharmaceutical To
Engineering
program.
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