PROCESS
VALIDATION
Process Design, Process Qualification, Continuous
Process Verification
September 29, 2009
WEBINAR
NOON - 1:30 pm EDT
This
Webinar will focus on discussing the new FDA proposed
(November 2008) guidance on Process validation. The
guidance promotes the implementation of a process-product
life cycle approach to verification that the process is
always in a validated state. The guidance defines three
distinct stages to process validation. These are:
Stage 1: Process Design
Stage 2: Process Qualification
Stage 3: Continued Process Verification
This
is not a new concept, although the guidance may suggest it
is. It was always important in the design and development
of the process to consider GMP implications and keep
validatability in mind. Process qualification or PQ was
always the necessary step confirming that the process is
capable of consistently producing a product that meets its
predetermined specifications and quality attributes. As
for continuous process verification, this has always been
a needed activity and was always accomplished through
process and product monitoring.
This
webinar will review these phases and outlines approaches
suggested for continuous process/product improvement.
During the webinar we will discuss the following:
Process
Design
- Defining the commercial manufacturing
process based on knowledge, risk assessment and
appropriate science.
- Using quality by design as defined in
ICH Q8
- Applying risk management techniques per
ICH Q9
- Applying quality system principles as
outlined in ICH Q10
- Consideration of process variability
- Establish a strategy for process control
and PAT
Process
Qualification
- Qualification of the facility, utilities
and equipment
- Develop a successful Performance
Qualification (PQ) approach
- Write a performance qualification
protocol
- Execute the PQ and develop the
report
Continued
Process Verification
- The validated state and maintaining it
- Develop a system for managing changes
(Change Control)
- Using routine monitoring, maintenance
and calibration procedures
- Continue to collect and analyze data
(PAT)
- Implement frequent QA and production
staff meetings
Find
strategies to improve the process through using data
collected,, CAPA, PAT
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, taught 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
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