A comprehensive analytical strategy which meets current regulatory expectations will reduce the cost of biosimilar development program (http://www.complianceonline.com/
For more information or to register for the seminar, please click here.
Seminar instructor Dr. Nanda Subbarao has extensive experience in evaluation of analytical methods and method validation for products ranging from pre-clinical to clinical and 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.
During the one and half a day seminar Dr Subbarao will focus on current status of global biosimilar guidance and analytical package required for a biosimilar product. She will also focus on analytical comparability studies currently required for comparison of the reference product with the biosimilar. Dr. Subbarao will also explain the analytical methods and specifications required for both comparability studies and lot release and stability studies.
The seminar will be valuable for regulatory personnel, R&D chemists, QC chemists, QA managers, supervisors and managers.
Date: Thursday, January 24 (8.30 AM-5PM PST) and Friday, January 25, 2013, (8.30 AM- 12PM PST)
Location: San Diego, CA
Registration Cost: $799.00 per registration
Early bird discounts: For discounts on early registrations, please click here.
Register by phone: Please call our customer service specialists at +1-650-620-3937 or email to customercare@
For more information on ComplianceOnline or to browse through our trainings, please visit our website
ComplianceOnline is a leading provider of regulatory/compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 20,000 professionals from 3,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at http://www.complianceonline.com.
For more information please contact:
A Reuben Bernard
Manager of Program Marketing
2600 E Bayshore Rd
Palo Alto CA USA 94303