Live Webinar
on
Best practices for conducting OOS investigations
Date & Time: Tuesday, November 15, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Nanda K. Subbarao
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
Nanda K. Subbarao Senior Consultant, Biologics Consulting Group, Inc.
This interactive webinar will review the regulatory requirements for an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed.
Why should you attend: FDA inspectors have in the past identified OOS Investigations as the leading cause for concern in Pharmaceutical laboratories. A review of the Warning Letters issued in the past year shows that OOS Investigations continues to be among the most frequently cited area.
Areas Covered in the Session: l l l l l l l
FDA requirements for handling OOS/OOT results Phase I- Laboratory Phase of Investigations Phase II – Full Scale Investigation Concluding an Investigation Out-of Trend investigations Common pitfalls during OOS Investigations Review of recent OOS related citations in Warning Letters
Click here to register for this webinar
Dr. Subbarao received her Ph.D. in Bio-organic Chemistry from the Indian Institute of Technology, Bombay, India. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products, ranging from preclinical phase to commercial phases. She is an ASQ Certified Quality Auditor with expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as well as upgrade of existing Quality Systems for products during development and in commercial phase....more
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Who Will Benefit: This course is intended to provide training how to perform OOS/OOT investigations l l l l l
QC Supervisors and Management QA Personnel
QA Management Documentation Management Specialists 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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