A
critical source of risk to patients using pharmaceuticals
to improve their health is inadequate design and control
of the processes that manufactured the drugs. Both R&D
and Manufacturing play a critical role in reducing risk
associated with poorly operating processes. The
publication of the ICH guidance documents Q8, Q9 and Q10
has heightened awareness in the pharmaceutical and biotech
industries of the need to reduce process risk. This trend
is also being promoted by the FDA as an approach to
process improvement with the benefit of enhanced
regulatory flexibility. But the questions remain: What
does it mean to reduce risk, to manage risk, and how do
you do it? Fortunately we have a lot of experience on
which to draw.
This
Webinar provides an overview of the strategies that have
been found to be useful in reducing risk including:
- Utilizing the relationship between
process variation, process understanding and process
risk
- Using a systematic approach to identify
the critical few variables that have a major impact on
the process:
- Raw materials, process steps, and
process variables and uncontrollable (environmental)
variables
- Increasing process stability and
capability
- Creating a process control
strategy
- Robustness studies of the product
and process
- Improvement of measurement performance
including improved control and robustness of analytical
methods
These
strategies and the associated guiding principles will be
discussed and illustrated with examples and case studies
from the pharma and biotech industries. The discussion
will focus on how to make the use of risk analysis and
risk management a reality for your processes.
Webinar
Leader: 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 has over 30 years experience working with
life sciences companies such as Novartis, Roche, DuPont,
Schering-Plough and Kraft. He provides guidance to senior
executives in their pursuit of improved business
performance using Quality by Design (QbD), Risk
Management, Lean Six Sigma and other improvement
approaches that produce bottom line results. He has
authored three articles on QbD, coauthored 4 books on the
tools of QbD and risk management 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, in addition to his books, has
published more than 200 papers in the fields of
performance improvement, quality, management, and
statistics.
