2010 Events

Date	Type of Event	Description
January 11	Special	Industry Speakers Needed! Sign up if interested by January 11.
January 12	Webcast	CGMPs for Combination Products: An Interactive Analysis with Industry and FDA
January 20	Open Meeting	Using CAPA to Strengthen and Improve Your Quality System
February 16	RAC Study Group	Spring RAC Study Group
February 24	Webcast	Auditing Suppliers and Contractors: Be Ready for Increased FDA Scrutiny
March 4	Webcast	Statistics for 510(k) Submissions
March 10	Open Meeting	Human Tissue and Tissue Products - An Overview of 21 CFR
June 9	Dinner Meeting	FDA Submissions Roundtable
TBD	QSR Class	The Essential Quality System Regulation Course.

History of Events from 2008 and 2009

2009 Events

January 28, Computer System Validation in an FDA Environment

February 18 to April 22, 2009: RAC Study Group

March 11, Bonfils Blood Center, Company Overview and Tour

April 22 meeting, Kurt Ammon, Operations Manager for the Rocky Mountain Poison and Drug Center, Adverse Event and Product Quality Complaint Contact Centers.

May 13, 2009, An Insider's View of the EU Medical Device Regulations.

June 25, 26, Webcast of live RAPS workshop.

July 30, Advanced Topics in Good Documentation for GXPs

August 19. Preparing for Your FDA Inspection

August 25 to November 3, RAC Study Groups

September 23, Panel Discussion: Personnel Training in a Regulated Environment: Challenges, Ideas and Solutions

October 14, QSR Class.

October 15, 16 Webcast, Medical Devices and IVD: A Practical Approach to the Japanese Market.

November 12 (rescheduled from October 28 due to weather), FDA Annual Update

November 17, Webcast, Quality System Audits: What You Must Do to Prove Compliance

December 2, 2009, Regulatory Changes in the European Market

December 15, 2009, Audioconference, Control of Products and Services Obtained from Suppliers.