RAPS Approved Webinar on
Common Problems with Software Validation Processes
Date & Time:
Course "Common Problems with Software Validation
Processes" has been pre-approved by RAPS as eligible for up to
1.5 credits towards a participant's RAC recertification upon full
Thursday, August 9, 2012 10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes Instructor: David Nettleton FDA Compliance Specialist,
Location: Online Price : $245.00 (for one participant)
David Nettleton, is an FDA
Compliance Specialist for 21 CFR
Overview: Part 11, HIPAA, and Computer
System Validation. His latest book is
This webinar covers the fundamentals of 21 CFR Part 11, software
"Risk Based Software Validation -
validation, and computer system validation. It provides details for Ten easy Steps" that relates to the
company compliance including GAMP, qualification, and validation. It development, purchase, installation,
teaches the Part 11 industry standards for SOPs, security, data operation and maintenance of
transfer, audit trails, and electronic signatures. The webinar details computerized systems used in
the common problems and how to avoid them. regulated applications. He specializes
in performing gap analysis,
remediation plans, SOP
Areas Covered in the Session: development, vendor audits,
training, and project management.
He has completed more than 185
l Learn how to avoid 483 and Warning Letters.
mission critical software validation
l Which software needs validation and which does not? projects. ...more
l Understand GAMP, qualification, and validation.
l Learn what the regulations mean, not just what they say.
l Examine the regulatory requirements for the three primary
Suggest a Topic More Webinars
areas of Part 11 compliance: SOPs, software product features,
and validation documentation. Your Necessity is our Priority
l Understand the current computer system industry standards
for security, data transfer, audit trails, and electronic
l Learn the Who, What, Where, When, and Why of computer
Click here to register for this webinar
Who Will Benefit:
l Laboratory staff
l 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.
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