Live Webinar on
Risk Assessment - Compliance Using Easy To Fill Out Documentation
Course "Efficient Risk Assessment - Compliance Using Easy To
Fill Out Documentation" has been pre-approved by RAPS as
eligible for up to 1.25 credits towards a participant's RAC
recertification upon full completion.
Date & Time: Instructor Profile:
Wednesday, June 20, 2012 10:00 AM PDT | 01:00 PM EDT
Duration: 75 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 teaches how to determine and document risk in a
"Risk Based Software Validation -
process in order to reduce validation time and ensure compliance. Ten easy Steps" that relates to the
development, purchase, installation,
What makes this session unique are the real life examples that make operation and maintenance of
application of the techniques understandable in the context of any computerized systems used in
validation project. It includes a workshop for participants to perform regulated applications. He specializes
their own hazard analysis so they are proficient in applying the risk- in performing gap analysis,
remediation plans, SOP
development, vendor audits,
training, and project management.
Areas Covered in the Session: He has completed more than 185
mission critical software validation
l Interactive real life examples.
l How to identify risk and establish mitigations.
l How to use the hazard analysis to make validation efficient.
Suggest a Topic More Webinars
l How to document the risk assessment using a template
l How risk assessment reduces validation time. Your Necessity is our Priority
l Determine risk in a process to reduce the testing effort.
l Traceability made automatic
l Workshop exercises.
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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