Event Theme: 50 Years, Your Partner in Quality

We are pleased to celebrate 50 years since the section was founded. Our event is comprised of two invited speakers, dinner, and a post-dinner panel discussion. Come meet some of the past section chairs and celebrate our section’s history.

Keynote Speakers

Marjorie Hook is a Senior Director of Sales Operations Process Optimization at Hewlett-Packard. Her organization is responsible for executing large scale process improvement in support of a multi-year transformation across H-P Sales Operations.

Kathleen Lewis is a 28-year Food and Drug professional and her current position is as District Director for the San Francisco District office. In her 28 years with the agency, she’s managed duties in a number of disciplines, such as Labeling and Dietary Supplements (CFSAN), Imports for Foods (Division of Food Defense and Targeting, formerly Prior Notice Center), Biologics and Tissue (CBER) , as well as field investigations and compliance. She has a bachelor’s degree in Biology, as well as having earned a professional degree in Health Law in 2009.

Kay Lewis will address how the quality program has affected the field at the operational level and the overall state of affairs with the ORA reorganization that is expected to be implemented in 2017 and has been in the planning stages for the past 2 years.

Michael Nausin will address the state of the FDA Quality Program and Systems. He works for our national quality program office in headquarters but is stationed in my office in Oakland. He has been involved in the development of ORA’s quality system program from the early stages.

Meeting agenda:

3:30 – 4:45 – Registration: Cocktails, finger-foods and networking (no host bar)
4:45-5:00 – Welcome Opening
5:00-5:30 – Keynote: Marjorie Hook, Senior Director, Sales Operations Process Optimization, HP
5:30-6:15 – Keynote: Kay Lewis, Director, San Francisco District, FDA, and Michael Nausin, National Quality Program Specialist, FDA
6:15-6:30 – Break
6:30 – 7:15 – Dinner
7:15-7:30 – 50 Years of Partnering in Quality Presentation
7:30-8:45 – Panel Discussion: Quality & Innovation

• Praveen Gupta: Noted author on quality & innovation
• Chuck Mignosa: President, BSA
• Kay Lewis:Director, SF District FDA
• Michael Nausin: National Quality Program Specialist FDA
• Marjorie Hook: Senior Director of Sales Operations Process Optimization, HP

8:45-9:00 – Closing Awards