Overview of Quality Assurance (QA) Functions and How We Work Cross-Functionally

ABSTRACT

The presentation will cover the following topics:

• QA organization structure and functions in the pharmaceutical industry

• Quality Key Performance Indicators (KPIs)

• Cross-functional team in the pharmaceutical industry

• Examples of how the team works cross-functionally

BIOGRAPHY

Sandip Patel is a Senior Manager, Quality Operations at Kyowa Kirin, a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. Sandip works in the Quality Operations team and provides quality leadership for North American products. Prior to Kyowa Kirin, he worked in the Quality Operations team at Bausch Health (Bausch & Lomb companies) and was responsible for quality oversight and management for contract manufacturing organizations. He received his Master of Science in Pharmaceutical Manufacturing from Stevens Institute of Technology, Hoboken, NJ, and has about 15 years of experience working in the QA department for both Clinical and Commercial products, performing various activities from QA lead for Clinical studies to new product launches for both internal and external manufacturing organizations.

For questions about the speaker, contact Prof. Leonid Shnayder