RISK-BASED APPROACH TO GMP
COMPLIANCE
Understanding FDA and ICH Guidances
and the ASTM Standard approach to Risk based GMP
compliance.
September 22, 2009
WEBINAR
NOON - 1:30 pm EDT
This Webinar will review the
background and guidance dealing with science and risk
based GMP compliance and the various approaches suggested
by FDA, ICH, and ASTM to mitigate risk and ensure proper
compliance is achieved. The documents that will be
reviewed include:
-
FDA Guidance “Pharmaceutical CGMP for the 21st
century – A Risk-based Approach” and its
implication.
Additionally subsequent progress reports issued by
the FDA regarding suggested approaches to mitigate risk
will be discussed
-
Review ICH Q8, Q9, Q10, and ASTM Standard
E2500
-
How does QbD fit within the big picture - ICH Q8
(R1)
-
What is meant by Product Life Cycle and
Manufacturing Life
Cycle
-
The jargon and acronym
definitions
We will discuss the knowledge, design and control
space concepts and their role in mitigating risk and the
concept of continuous improvement and how to achieve it.
Instructor: Gamal Amer, Ph. D.
Dr. Amer
is Principal at Premier Compliance Services, Inc.;
Management Consultants for compliance and manufacturing
operations performance in the life sciences industry. He
holds a Ph. D. in Chemical Engineering and has over 30
years of experience in the Pharmaceutical and related
industries. He has held positions of increased
responsibility with leading pharmaceutical, consumer
product and engineering consulting firms over the years.
His experience includes comprehensive process design in
bulk pharmaceutical manufacturing, biotechnology
manufacturing, pharmaceutical solid dosage manufacturing
and containment of potent and radioactive therapeutics. He
is also experienced with facility development for
therapeutic products operations. Dr. Amer is a recognized
expert in GMP compliance and validation. He has consulted
for many of the leading pharmaceutical, biotechnology and
medical device manufacturers. He has lectured extensively
in the US, Europe, Asia and the Middle East, tau ght many
courses, and authored many papers which were published in
peer reviewed publication. He is a member of ISPE, PDA,
ACS and AIChE.
FEE: $345
for one person.
Call for
special discounts for multiple participants from your
company.
610-399-4897
ECCWEB129
|
