How to Bullet Proof your Documents from Most Commonly Cited GDP Violations

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How to Bullet Proof your Documents from Most Commonly Cited GDP
Violations


Course "How to Bullet Proof your Documents from Most
Commonly Cited GDP Violations" has been pre-approved by

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RAPS as eligible for up to 1.00 credits towards a participant's
RAC recertification upon full completion.
Date & Time:
Instructor Profile:
Tuesday, July 3, 2012
10:00 AM PDT | 01:00 PM EDT
Chinmoy Roy
Duration: 60 Minutes
Instructor: Chinmoy Roy
Biopharma Consultant,
Location: Online
Price : $245.00 (for one participant)
Chinmoy is a seasoned Life
Sciences professional. His expertise
Overview:
includes the design, delivery and
validation of industry compliant
Good documentation is a cornerstone for good operational practices
computerized and control systems
in any biopharmaceutical company. While documentation is a CFR
for pharmaceutical and biotech
requirement, there is no specific regulatory guidance on good
manufacturing. His focus is on
documentation practices. A company's documentation system and
finding lean integrated
practices are vital to a successful audit since it provides regulators a
manufacturing solutions to include
window into the company's operations. It is one of the systems
Quality by Design (QbD) and Quality
which always attract the attention of regulators.
Risk Management (QRM).
He has more than 35 years of hands
The objective of this webinar is to provide attendees with a
on industry experience in directing
comprehensive understanding of the Good Documentation Practices
the implementation, validation and
(GDPs) requirements. After completing this webinar, the participants
obtaining "fit for use" certification of
should be knowledgeable on the current regulatory thinking on good
large biopharmaceutical
documentation to include not only paper documentation but also the
manufacturing automation and IT
evolving electronic documentation standards
systems. These systems conform to
regulatory requirements such as CFR
21 Part 11 and Annex 11. He has a
Why Should You Attend:
very broad experience in facilitating
Documentation system is one of the systems that is always audited.
QRM sessions for large US
companies and has provided them
It is rare to find a audit which does not issue a 483 for poor
with consultant oversight to establish
documentation. Add to this a level of complexity introduced by
their Quality Risk Management plans.
documentationn in the electronic realm and soon we inccrease our
...more

vuknerability to receiving 483s for documentation. BY attending this
webinar, you will become familiar with the complexities and
challenges posed byy hybrid documentation systems and steps you
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abosolutely need to take to ensure that your documentation system
is bullet proof.
Your Necessity is our Priority
Areas Covered in the Session:
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Document types and their quality attributes

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How to correct errors and omissions
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Document identification and referencing requirements
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How to sign, date and label data
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Requirements for electronic documents
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Unique requirement for SOPs
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Document management
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GDP related 483s and Warning letters
Click here to register for this webinar
Who Will Benefit:
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Project Managers
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Lead Engineers
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Software Engineers
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Documentattion Managers
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Document System Control Personnel
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R&D
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Contractor
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Consultants
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QA
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Regulatory Affairs

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Engineering
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IT personnel
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,
Event-coordinator
GlobalCompliancePanel
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