4 March 2016
7:30 am – 4:30 pm
Crown Plaza Foster City
Foster City, CA
Join your quality and regulatory colleagues from ASQ Northern California Biomedical and the RAPS San Francisco Bay Area Chapter for a lively and informative workshop that explores effective methods for avoiding common 483 observations and Notified Body audit non-conformities.
Food and Drug Administration, Notified Body and industry presenters will take a deep dive into key areas where device and diagnostic companies often have compliance struggles. Interactive sessions will highlight GMP systems, with particular focus on CAPAs, Complaints, Design Control, and Risk Management, and use these as a framework for discussing what’s not working and best practices for how to get it right. In a bonus segment, a Notified Body Director will provide insight into an auditor's focus during the MDSAP process.
This workshop will benefit regulatory, quality and R&D personnel from device and diagnostic companies.
Speakers:
Eric Anderson, supervisory consumer safety officer, Food and Drug Administration
Bradley Chen, director, medical products division, TUV-USA/Nord
Denise Dion, vice president regulatory and quality services, EduQuest, Inc.
Mary Beth McDonald, senior director, quality assurance, Chrono Therapeutics
Rob Sestrick, principal, EiQ Consulting
Date/Time:
Friday, 4 March 2016
7:30–8:30 am Registration Check-in and Networking Breakfast
8:30–12:00 pm AM Presentations and Panel Discussions
12:00–1:00 pm Luncheon
1:00–4:15 pm PM Presentations and Panel Discussions
4:30 pm Closing and Adjourn
Location:
Crowne Plaza Foster City
1221 Chess Drive
Foster City, California 94404
» Get directions online, or call +1 650570 5700
Registration:
RAPS and ASQ Members: $175 Nonmembers: $200
Registration Form (PDF) - for registration by mail or fax.
Local Contacts:
Barry Craner, ASQ Biomedical Division
Shaalini Doan, RAPS SF Chapter
Michelle Ragozzino, RAPS SF Chapter
Registration Questions:
Shweta Kaushik, RAPS SF Registration Chair
Wesley Carr, RAPS