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Cost Effective – Time Effective –
In your Conference Room or Office
Validation
Protocol Development
and Acceptance Criteria
Conducted by Gamal Amer, PhD
Senior Director of Technology and Compliance at BE&K, Inc.
April 25, 2008
The validation protocol is
the road map, which guides the qualification effort for a given piece of
equipment or system. It not only describes in detail what experiments would
be conducted but also serves as a repository of the data collected during
the execution of the document. The validation protocol also defines the
objective results to be met by the testing; these are usually referred to as
predetermined acceptance criteria. This seminar will show you how to define
the acceptance criteria and develop a successful protocol.
This seminar begins by describing the
industry standard for using protocols to complete the validation effort. It
then proceeds by defining what each protocol’s objective is. Next is
defining the contents of a typical validation protocol and real life
examples to illustrate the points being made. We will discuss protocols for
utility systems, process equipment and cleaning validation. Additionally,
the presentation will provide ideas as to what should be included into the
various sections of the protocol. Finally, we will discuss steps to be taken
to ensure the protocol is developed and approved easily and on a timely
basis. These suggested steps would result in increasing the probability that
the protocols will be developed and executed with a minimum number of
rewrites and deviations.
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.
Validation
Protocol Development and Acceptance Criteria
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Part I Validation Protocol
Development and Acceptance Criteria
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Defining validation
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Determining the need
for protocols
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Determining how
validation is conducted
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Defining the various
types of protocols
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Determining acceptance
criteria and how to define them for use in protocols
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The basic contents of
validation protocols
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What the protocols
should accomplish
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What it takes to develop an effective protocol and getting it
approved
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Part II Questions and Answers
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Register now!
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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
GMP080425E - CD and
Handout materials
Validation Protocol Development and Acceptance Criteria
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
Dr. Amer is a recognized technical expert in
Pharmaceutical manufacturing. His expertise also covers GMP compliance and
validation. He has lectured extensively in the US, Europe, Asia, and the
Middle East and taught many courses on subjects such as controlled release
technology, design of Biotech facilities, GMP trends, Process Analytical
Technology, Cleaning Validation, Process Validation, Validation and Change
Control, and implication of GMP compliance on process and facility design in
the biotechnology industry.
Please forward this to your colleagues who may be
interested.
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