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Cost Effective – Time Effective –
In your Conference Room or Office
Master Planning for
Validation: Doing it Right!
Conducted by Gamal Amer, PhD
Senior Director of Technology and Compliance at BE&K, Inc.
April 18, 2008
The Validation Master Plan (VMP)
is a scope document aimed at outlining the approach of validating the
healthcare product production facility and process. Its intent is to define
and enumerate critical systems to be validated and outlines the approach to
validate such systems. The VMP’s main objective is to outline in sufficient
detail the approach to be taken by an organization to develop documented
evidence that the process used to manufacture the Pharmaceutical,
Biopharmaceutical or device, will result in a product which meets its
predetermined quality attributes. This presentation will discuss a pragmatic
way of getting it done.
This web-seminar presents a
recommended validation approach and will define the
contents of a typical validation master plan. This seminar will also present
real life examples to illustrate the points being made. Additionally, the
presentation will provide ideas as to what should be included into the
various sections of the VMP. Finally, we will discuss steps to be taken to
ensure the VMP is developed on a timely basis and earn the buy-in and
commitment from all stakeholders within the organization. Following this
approach would result in increasing the probability that the VMP will be
approved and successfully implemented.
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.
Master Planning
for Validation: Doing it Right!
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Part I Validation and Master
Planning
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Defining validation
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Defining how
validation is conducted
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Determining the need
for a validation master plan
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The basic contents of
a master plan
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Identifying what each
section should contain
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Identifying which
systems require validation
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How to schedule
validation activities
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What it takes to develop an effective Master Plan
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How to get your
Master Plan 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
GMP080418E - CD and
Handout materials
Master Planning for Validation:
Doing it Right!
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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