October 29, 2009 - 510 K Submissions by the Anson Group

The Midwest Discussion Group of the ASQ Biomedical Division Presents:

510 K Submissions by the Anson Group

Meeting Location: University of Indianapolis
Schwitzer Student Center Building #7 Room #013   (located on the lower level)
See U of I web site for campus map & driving directions.  Parking is open after 5:00 pm.
Time: 5:30 pm till 6:00 pm Networking & Meal
6:00 pm till 8:00 pm Discussion session.

Hear what Colleen Hittle has to say about 501K Submissions.

Managing Partner Colleen Hittle, RAC, coordinates and directs Anson’s FDA practice, overseeing a staff of more than 80 staff and contract consultants and specialists. Under her direction, Anson’s capabilities have expanded to include corporate compliance assessment, compliance risk management, and other innovative services. Ms. Hittle has been an active participant in industry group dialogues with the FDA on such issues as combination product approval procedures and drug/device cross-labeling. Ms. Hittle is a Purdue Engineering graduate who spent 8 years in industry quality system and regulatory technical and management roles before joining the Anson Group in 1997.

This Roundtable Discussion will utilize the synergy of our well-versed Subject Matter Expert along with your Regional Industry Peers.

We have recently changed registration services to Acteva for our discussion group events.  This will require you to set up an account the first time you register for an event.  It is quick and will expedite future registrations.