Validation
of Heating Ventilation and Air Conditioning Systems
May
18, 2010 WEBINAR
12
- 1:30 pm EST
Registration
fee below for one
dial-in, one person. Call for discounts to register more than
one person.
Heating Ventilation Air
Conditioning (HVAC)
systems represents one of the most critical utilities in the
biopharmaceutical industry. These systems are the key to cleaning and
conditioning the air used in the manufacturing facilities for drug
products. They also play a key role in preventing microbial as well as
cross contamination of the drugs during manufacture. This Web-seminar
will discuss the characteristics of the HVAC system and how to ensure
the system is properly validated. The discussion will focus on applying
the principles outlined in the proposed FDA guidance on Process
Validation issued in November 2008.
We will address the activities
which should
take place during the design and development of the HVAC system for the
biopharmaceutical manufacturing operation as the first step in
validating the system. Then we will address the appropriate activities
which should take place during the implementation and qualification
stage. The discussion will consider verification activities as well as
Performance Qualification (PQ) and how to develop the appropriate
protocols, design the correct tests, and define the proper acceptance
criteria to ensure the system is qualified. We will then consider the
protocol execution phase and how to ensure that the system is fit for
the intended use. Finally, we will review the appropriate activities to
continually verify and ensure the system remains in a validated state
through conducting environmental monitoring and applying change control.
By participating in this
presentation you
will learn:
- What the applicable regulatory
requirements
are?
- What are the appropriate design
steps and
the resulting documentation?
- How to qualify the HVAC system
and what the
protocols would look like?
- How to define the acceptance
criteria?
- What constitutes continued
verification and
how to maintain the validated state?
- Monitoring, statistical
trending, and review
of critical environmental data to verify proper control of the required
conditions.
- Using the data from monitoring
to assess the
effect of seasonal variations.
- Using data gathered during the
continued
process verification to improve and/or optimize the systems.
At the end, Dr. Amer will field
your
questions live. You will hear all questions and answers from all
participants of this seminar.
FEE:
$365 for one dial-in, one person.
Call to register more than one person.
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.
REGISTER NOW! CLICK HERE!
610-399-4897
ECCWEB180
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