Best practices for conducting OOS investigations

Live Webinar on

Best practices for conducting OOS investigations
Date & Time:


Tuesday, November 15, 2011
10:00 AM PDT | 01:00 PM EDT

Register Now

Duration: 90 Minutes
Instructor: Nanda K. Subbarao
Location: Online
Price : $245.00 (for one participant)

Instructor Profile:
Overview:
Nanda K. Subbarao
This interactive webinar will review the regulatory requirements for
Senior Consultant, Biologics
a n OOS Investigation. The responsibilities of the analyst, the
Consulting Group, Inc.
supervisor and QA will be discussed.

Dr. Subbarao received her Ph.D. in
A detailed flow chart will be used to help the attendees clearly
Bio-organic Chemistry from the
understand the steps and the order in which they are to be
Indian Institute of Technology,
performed.
Bombay, India. Her hands-on
industrial experience covers stability

and laboratory cGMP systems for
Why should you attend:
both biologics and conventional
drugs. She has extensive experience
FDA inspectors have in the past identified OOS Investigations as the
in evaluation of analytical methods
leading cause for concern in Pharmaceutical laboratories. A review of
and method validation for products
the Warning Letters issued in the past year shows that OOS
ranging from conventional drugs,
Investigations continues to be among the most frequently cited area.
well characterized proteins,

vaccines, cell therapy and gene


therapy products, ranging from pre-
clinical phase to commercial phases.
Areas Covered in the Session:
She is an ASQ Certified Quality
Auditor with expertise in setup of
cGMP/GLP complaint Quality
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FDA requirements for handling OOS/OOT results
Systems for laboratory and stability
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Phase I- Laboratory Phase of Investigations
programs as well as upgrade of
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Phase II - Full Scale Investigation
existing Quality Systems for
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Concluding an Investigation
products during development and in
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Out-of Trend investigations
commercial phase....more
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Common pitfalls during OOS Investigations
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Review of recent OOS related citations in Warning Letters
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Your Necessity is our Priority
Who Will Benefit:
This course is intended to provide training how to perform OOS/OOT
investigations

l
QC Supervisors and Management
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QA Personnel
l
QA Management
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Documentation Management Specialists
l
Regulatory Affairs 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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