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Cost Effective – Time Effective –
In your Conference Room or Office
Effectively
Implementing CAPA (Corrective and Preventive Action):
A Risk Mitigating Quality System
Conducted by Gamal Amer, PhD
Senior Director of Technology and Compliance at BE&K, Inc
February 15, 2008
The
prevalent method defined by the regulators (FDA, EU, …) and the industry
for defining and mitigating risk is “Corrective Action Preventive Action,”
otherwise referred to as CAPA. This seminar will help you define what is
meant by risk. We will explore the factors associated with compliance risk.
Then we will explore risk causing events and how to address them. A review
of risk severity/level will be discussed. Upon completion of the risk part
of the presentation we will define what a CAPA system would look like.
This seminar will focus on CAPA as it
applies to risk mitigation. We will define what we mean by a CAPA system. We
will further define the tools CAPA uses during implementation. Finally an
overview of a CAPA system will be presented and a CAPA approach will be
proposed. The approach will focus on defining the specific steps to be taken
when implementing a CAPA system and review some of the possible pitfalls one
may encounter when implementing a CAPA system. We will then review some of
the benefits which may accrue by having a robust CAPA system in place.
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.
Effectively Implementing CAPA
(Corrective and Preventive Action):
A Risk Mitigating Quality System
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Part I Risk as it Applies to
Compliance
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What is risk?
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How to define the levels of risk
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What events may cause, or increase the
potential of risk?
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How risk manifests itself
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Part II CAPA as a Method to
Mitigate Risk
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Learn how to identify non-conformances and deviations
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Learn how to document a non-conformance and deviation
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Evaluation and risk assessment of non-conformances and
deviations
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Learn what information is needed to evaluate non-conformances
and deviations
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Learn how to address non-conformances and deviations within a
CAPA program
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Learn how to investigate and determine the severity of
non-conformance and deviations
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Learn how to track and dispose of non-conformances and
deviations
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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
Effectively Implementing
CAPA
GMP080215E - CD and
Handout materials
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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