ASQ-SF "Welcome Back" Event December 11, 2008

Network and Learn -- Attendance is Free!

After a few years without formal activities, we're happy to announce that the San Francisco Section of ASQ is back in business, and our first event is Thursday, December 11, from 6:00 pm to 9:00 pm at the Hyatt Regency Hotel (5 Embarcadero Center, Downtown).

There will be plenty of time for networking before and after the formal presentation, "Preparation for FDA Inspections and What to Do During and After the Inspection," by Ken Miles, Former FDA Investigator.

And for this first "welcome back" event, attendance is free, not only for ASQ-SF (Section 604) members, but also for other ASQ section members, as well as non-ASQ members. Simply RSVP via the link below, and join us for networking, learning, and just finding out what we've planned for ASQ-SF in the coming year. Refreshments (cookies, brownies, sodas) will also be available.
We look forward to seeing you!

(Even if you can't join us, please stay tuned to www.ASQ-SF.com for news, updates, and useful information.)

Preparation for FDA Inspections and What to Do During and After the Inspection

Network with other quality professionals before and after the formal presentation at this free "welcome back" event!

This presentation will cover the Food and Drug Adminstration's general process for conducting inspections at manufacturing facilities, how to prepare for future inspections, what to expect during an inspection, different levels of inspectional findings, and what to do following the inspection. The presentation will focus on inspections of medical device manufacturers, but will also cover other regulated industries such as pharmacueticals and food. A Question and Answer session will follow the presentation.

This presentation is intended for:
· Managers from FDA-regulated companies producing medical devices, drugs, cosmetics, foods and radiological devices
· Non-FDA regulated companies that are subject to inspections by other regulated agencies
· Regulatory Affairs and Quality Assurance managers and staff
· Production managers and supervisors

Speaker: Ken Miles, Former FDA Investigator, now Quality Systems Consultant and Sole Proprietor of Alpha Quality. While serving as an FDA medical device investigator, he traveled to many countries around the world to enforce FDA regulations, and as a consultant. For the past 5 years, he has helped FDA regulated companies of all sizes to improve compliance with FDA regulatory requirements and ISO requirements, and to improve key SOPs and working instructions to implement effective processes and operations for producing safe products for the marketplace.

RSVP by clicking here or pasting the following URL into your browser::
http://asq-sf.com/index.php?option=com_contact&view=contact&id=8%3Aevent-rsvp&catid=12%3Acontacts&Itemid=76
Where & When

Hyatt Regency Hotel San Francisco
5 Embarcadero Center, San Francisco, CA 94111
(Steps away from Embarcadero BART/Muni Station, with garage parking available across the street for $3/hour after 5pm)

Thursday, December 11, 2008
6:00 - 6:30 pm Registration
6:30 - 7:00 pm Networking
7:00 - 7:45 pm Presentation
7:45 - 8:00 pm Q&A
8:00 - 9:00 pm Networking

Refreshments (cookies, brownies, sodas and water) will be served.

Official Website: http://www.ASQ-SF.com