2012 Events

 Date

 Type of Event

 Description

 January 27
 Class The Essential Quality System Regulation Course
   


History - 2011 Events

Date

Type of Event

Description

January 19
Open Meeting
How not to ruin a perfectly good product with a perfectly flawed study design.
January 26
Webcast
The Challenge of Developing a Regulatory Intelligence Network to
Support Global Clinical Trials:  Communication & Collaboration.
February 8
RAC Study Group
Preparation for US RAC Exam - Study Group
February 16
Webcast
FDA's New 510(k) Action Plan:  Changes for 2011
March 9
Open Meeting
Tales from the Crypt: 
A Previous FDA Medical Device Investigator's Web of Real-life Inspection Stories
March 31
Seminar
The Essential Quality System Regulation Course
April 1
Seminar
CAPA Boot Camp
April 20
Open Meeting
Navigating the Electronic Maze:  Practical Advice for Companies
June 15
Open Meeting
FDA Medical Device Regulations:  An Overview for Beginners
August 17
Open Meeting
Regulatory Chat Mixer
August 25
Webcast
Complaint Handling
Sept 8
Study Group
RAC Study Group

Request for Volunteers
Sept 28
Webcast
Surviving the FDA's New PREDICT Import Screening Program
Oct 19
Open Meeting
Mitigating Risk in the Supply Chain Based on Regulatory Requirements
Oct 30
Webcast
What needs to be in a product submission:  An FDA Reviewer's Perspective.
Nov 14
Webcast
Building a Better 510(k): Suggestions from Inside FDA
Dec 7
Open Meeting
Annual FDA Update


History - 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 22
Open Meeting
Process Validation - Current Regulatory Expectations
September 23
QSR Class
 The Essential Quality System Regulation Course.
November 3
Open Meeting
RMRAS Annual FDA Update, Tom Warwick, Director of the FDA Denver District
December 7
Open Meeting
 Recent Warning Letter Trends


History - 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.


History - 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.