Office Hours with Sean O'Donnell, Experien Group
Quality Management Systems - February 13th
Our office hours are hosted by leading experts who have generously offered their services pro bono to our entrepreneurs.
To hold your slot for this session, we require a $100 credit card deposit. The deposit will be refunded the day after you attend. No-shows will not receive a refund. Please be punctual; arrivals late by more than 15 minutes will be considered no-shows.
To Sign Up:
- Select your time slot below and fill in the information
- Make the refundable* deposit payment below or by clicking here
- You are done!
*Please note that you may request a refund up to 48 hours in advance. (This will give us time to offer the time slot to the first person on the waitlist.) We regret that we cannot honor requests made at a later time.
If all scheduled slots are full, please sign up for a waitlist slot. If an opening appears, we will contact people in the order they signed up. Waitlist time slots will be confirmed 48 hours prior to office hours. Deposit payment will be required upon time slot confirmation.
Byers Hall, Suite 214, UCSF Mission Bay
1700 4th St, San Francisco, CA 94158
About Sean O'Donnell:
Sean O'Donnell is the Chief Quality Officer for Experien Group, a medical device consulting firm headquartered in northern California that helps companies develop and execute successful FDA and international regulatory programs. In addition to managing the Quality team, Sean holds particular expertise in software-based technologies as well as usability engineering standards for complex medical devices. He supports clients’ U.S. and international regulatory submissions and functions as Experien Group’s interface with regulatory agencies through audits and inspections. Sean has completed AAMI Certification for Mastery of the Quality System Regulation and a Lead Assessor Program for ISO 9000 with emphasis on ISO 13485. He was a certified instructor on Process Validation for Siemens Medical Solutions and Boston Scientific and a course instructor for De Anza College Center for Applied Competitive Technology. Sean achieved a B.S. from San Jose State University in Chemical Engineering.