21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits

Live Webinar on

21 CFR Part 11 and Annex 11; What you Need to Know to Pass the
New Regulatory Audits
Date & Time:


Tuesday, August 16, 2011
10:00 AM PDT | 01:00 PM EDT

Register Now

Duration: 90 Minutes
Instructor: David Nettleton
Location: Online
Price : $245.00 (for one participant)

Instructor Profile:
Overview:
David Nettleton
This webinar details both regulations and provides details for
FDA Compliance Specialist,
implementing computerized systems.

David Nettleton, is an FDA
Learn exactly what is needed to be compliant for all three primary
Compliance Specialist for 21 CFR
compliance areas: SOPs for the IT infrastructure, industry standards
Part 11, HIPAA, and Computer
for software product features, and the 10-step risk-based validation
System Validation. His latest book is
approach. This webinar demystifies Part 11 and the new European
"Risk Based Software Validation -
equivalent Annex 11. It gets you on the right track for using
Ten easy Steps" that relates to the
electronic records and signatures to greatly increase productivity.
development, purchase, installation,

operation and maintenance of
computerized systems used in
Areas Covered in the Session:
regulated applications. He specializes
in performing gap analysis,
remediation plans, SOP
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Which data and systems are subject to the regulations?
development, vendor audits,
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What the regulations mean, not just what they say.
training, and project management.
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Avoid 483 and Warning Letters.
He has completed more than 185
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Examine the regulatory requirements for the three primary
mission critical software validation
areas of Part 11 compliance: SOPs, software product features,
projects. ...more

and validation documentation.

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Ensure data integrity, security, and protect intellectual
property.
Suggest a Topic
More Webinars
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Understand the current computer system industry standards
for security, data transfer, and audit trails.
Your Necessity is our Priority
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Electronic signatures, digital pens, and biometric signatures.
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Evaluate the regulatory requirements related to the current
computer system standards for security, data transfer, audit
trails, electronic signatures, digital pens, and biometric
signatures.

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SOPs required for the IT infrastructure.
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Product features to look for when purchasing COTS software.
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Reduce validation resources by using easy to understand fill-
in-the-blank validation documents.
Click here to register for this webinar
Who Will Benefit:
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IT
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QA
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Q C
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Laboratory staff
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Managers
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GMP, GCP, GLP professionals
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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