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Cost Effective – Time Effective –
In your Conference Room or Office
Environmental Monitoring:
The True Reasons
Conducted by Gamal
Amer, PhD
Principal - Premier Compliance Services, Inc.
July 11, 2008
FDA expects pharmaceutical manufacturers to
be in control of the environmental conditions
within the manufacturing facility. Controlling
the environmental condition is not only a
regulatory requirement but also part of
protecting and producing a quality product. This
presentation will define what is meant by
environment, what conditions are required and
how such conditions may be dictated by the type
of product being processed.
The presentation will then proceed to
discuss how to obtain the desired environmental conditions, manage the
conditions within the space, and what is required to ensure that the
environmental conditions remain in a state of control. We will define
standard environmental conditions to be maintained in manufacturing space
based on published standards and compendial documents. A hypothetical
biotech manufacturing facility will be used as an example to show the use of
various conditions as they apply to various activities with the processing
of a Biotech product.
The discussion will then describe
various methods to monitor such conditions and where to monitor within the
space. The frequency of the monitoring will be reviewed based on the
criticality of the activity being performed in the space. We will emphasize
how to collect the data and what to do with the data once collected.
Trending, identifying alert and action limits will be defined and possible
preventive and corrective actions will be reviewed.
Through out the presentation we will
review actual FDA 483 observation as they relate to environmental monitoring
to emphasize the issues of most concern to the regulators. We will allow
some time for Q&A at the conclusion of the seminar.
This seminar will be
conducted on the telephone and is presented by
Gamal Amer, PhD, an industry expert on this and
other compliance related topics.
In this unique web
seminar format, lasting just one hour, you will be able to
follow along with a PowerPoint presentation,
ask questions, and interact with Dr. Amer. An outline of this
seminar and Dr. Amer's qualifications can
be found below.
Environmental
Monitoring: The True Reasons
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Part I Controlling the
manufacturing environment
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Part II Environmental
monitoring and how to do it
Using an example of a
fictitious manufacturing facility, you will learn:
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The basic methods to monitor
the environment
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Where to monitor within the
space
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What variables you should
monitor
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The frequency of monitoring
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What to look for to identify
potential problems
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Part III Questions and Answers
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Register now!
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Call us at 714-289-1233
All registrations include handout materials. Once you’re registered, you will
receive via e-mail (the e-mail address you provide in your registration) the web location to download the handout materials.
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Get the CD and handout
GMP070523E - CD and
Handout materials
Environmental
Monitoring: The True Reasons
CD price includes all HANDOUT MATERIALS and audio
CD. CD will be shipped three weeks after the seminar |
$397.00 |
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Instructor
Gamal Amer, PhD
Gamal Amer, Ph. D. 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 two decades
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.
Please forward this to your colleagues who may be
interested.
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