Key Note Speaker Biography & Presentation Information

16 Apr 2019

Speaker Bio
Name: Shanthi Vadali
Employer: St Jude Children’s GMP LLC.,
Position: Scientist
Organization Industry: Cellular and Gene Therapy
Affiliations/Certification: Certified Biomedical Auditor
Education: PhD

Presentation topic
Title: Quality by Design during development and manufacturing of a product.
Summary: Quality by Design, also known as standard of practice is integrating consumer
needs, science and quality requirements during the development of a product and its
manufacturing process. The key is to attain consistent product with low risk of failure during
manufacturing.