Live Webinar
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Does your Equipment Program Meet Current Regulatory Expectations
Date & Time: Thursday, October 20, 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: This Interactive webinar will begin with an overview of the GMP/GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/GLP compliance will be reviewed.
Why you should attend: The equipment Program is a critical component of both GMP and GLP laboratories. It contributes to the quality and therefore reliability of the generated data which is required for critical for go-no-go decisions. An effective Equipment Program is also an expectation in GLP and GMP laboratories.
Areas Covered in the Session: l l l l l l l
FDA requirement for Equipment systems Overview of GMP/GLP requirements for equipment IIQ/OQ/PQ of Equipment Equipment database Equipment SOPs Equipment Calibration and maintenance Review of equipment related citations in recent Warning Letters
Nanda K. Subbarao Senior Consultant, Biologics Consulting Group, Inc. 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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Click here to register for this webinar 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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