Why Should You Attend:
This webinar will address the requirements for facilities engaged in non-clinical GLP studies. The regulatory requirements for the quality systems required for planning, performing and documenting GLP studies will be discussed. Practical steps to be taken to ensure the requirements for personnel involved in these studies, the facilities in which they are conducted and the equipment use for conducting the studies will be addressed. The roles and responsibilities of the Study director, Quality Assurance the Archivist will be described.
The webinar will also discuss the steps involved in a GLP study. The requirements for batch release of the Test Article and requirements for a Study Protocol will be addressed. Lab operations in a GLP complaint laboratory where GLP studies are conducted will discussed followed by how to prepare a GLP report and how all GLP reports must be archived.
This webinar will include a discussion of recent warning letters and will focus the attendees on current hot topics in this field. In particular recently clarified regulatory expectations regarding Data Integrity and the warning letters issued to non-compliant organizations will be discussed.
Areas Covered in the Webinar:
Who Will Benefit:
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 pre-clinical 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.
She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She serves on the AAPS Stability Focus Group Steering Committee. She also serves on the AAPS National Biotechnology Conference Programming Committee for 2009 to 2011 as the Regulatory Sciences lead.
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