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
April 6
Webcast
Reimbursement in 2010 and Beyond:  Understand the Changing Legal Landscape
April 12, 13
Webcast
Medical Device Submission & Compliance Strategies
May 5
Open Meeting
Complaint Handling - The "Big" Picture
June 8
Webcast
SOPs; Advanced Problems & Solutions
June 9
Dinner Meeting
FDA Submissions Roundtable
July 29
Webcast
Maintaining a Complete Design History File
August 4
Open Meeting
Electronic Submission Awareness
Aug 31 to Nov 2
Study Group
RAC EU Study Group
September 2
Webcast
510(k)s: The 70 Changes FDA Wants
September 23
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.

2008 Events

August 28:  Webcast; CAPA Management

September 24:  Risk Management Conference; PPA Event Center

October 3:  QSR Class, PPA Event Center

November 12:  FDA Update, Tom Warwick, FDA Denver District Director

November 19, 20:  FDA Clinical Trial Requirements

December 2: Webcast, GMPs for Investigational Drug Products.

January 14, OTS Software Validation.