Group Leader and Senior Consultant
Dr. Subbarao is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products ranging from conventional drugs to well characterized proteins and vaccines, from pre-clinical phase to commercial phases. She has been involved several times over her career in projects to setup or upgrade cGMP/GLP complaint Quality Systems for laboratory and stability programs for products during development and in commercial phase. She participates in the AAPS Stability Focus Group Steering Committee.
Live Sessions Not Found.
Evolving Regulatory Expectations for Data Integrity in GMP laboratory
Data Integrity has become an increasing concern for Regulatory Agencies worldwide. The majority of the laboratory related warning letters in 2015 focused on this area. A review of Data Integrity failures indicates that the root causes include employee errors and lack of adequate data reviews, inadequate laboratory instrument software system, and configuration problems associated with laboratory electronic data and malfeasance by employees. The FDA issued a draft guidance in April 2016 on Data Integrity which when issued in final form will have wide implications on how raw data, both electronic and paper, is to be generated, reviewed and archived. This webinar addresses the key elements of regulatory expectations for Data Integrity in the GMP Laboratory.
Get life time access for one participant with download option!
SUBSCRIBE TO NEWSLETTER
Get industry updates and exclusive deals on offers!