Calendar of Events
Meeting Schedule for 2008
|
Date |
Subject |
Speaker |
Location |
|
January 16 |
Electronic Documents, Part 11
|
TK Train, Gambro |
Sheraton Denver West |
|
Feb 27 |
Ask the Experts: 510(k) submissions |
Mike Quinn Patti Arndt |
- |
|
April 9 |
Nutritional supplement regulations |
Kevin Morningstar Evelyn Cadman Shelly Maifarth |
Koebel Library |
|
May 19 |
Half-day event; Joint Session with CBSA; labeling and advertising |
Tom Warwick, Director FDA Denver District | The Brown Palace |
|
June 25 |
Chemistry Manufacturing Controls | Robert Kasubik | Front Range Community College |
|
August 6 |
Overview of Canadian regulations and device licensing | Kevin Randall | TBD |
|
Sept 17 |
Tentative: Risk Assessment/ Risk Management (All-day session; address product issues and incorporation of risk into other QMS activities; include FDA perspective and possibly Notified Body rep) | TBD | TBD |
|
Nov 5 |
Tentative: Presentation by Denver District | TBD | TBD |
| Dec 10 |
Tentative: Consider a QSIT all-day, either CAPA or Design Control Alternative: Software validation, to include product, process, and Part 11 issues |
TBD | TBD |
RAC Study Group
The RAC Study Group convenes August 15 and meets every Wednesday for 12 weeks.
(Click here for more information.)
QSR Class
- The most recent class was conducted on November 2, 2007. The next class has not yet been scheduled.
(Click here for more information)
Conferences
The QSIT series is on hold at this time.
- Management Controls
- Corrective and Preventive Action (CAPA).
- Design Control
- Production and Process Controls
For Reference: Meeting Schedule for 2007
|
Date |
Subject |
Speaker |
Location |
|
January 24 |
FDA Update and Panel Discussion
|
Belinda Collins, FDA Denver District Director |
Sheraton Denver West |
|
March 7 |
Ask the Experts - Design Assurance |
Kevin Morningstar Nancy Sauer |
Front Range Community College |
|
May 9 |
Ask the Experts - Process Validation and Sterilization Validation |
Bruce Tive Mark Dott |
Koebel Library |
|
June 20 |
Anita Powe Thai Duong |
PPA Event Center |
|
|
August 1 |
Fitzsimons Tour |
NA |
Fitzsimons |
|
Sept 12 |
Electronic Document Management Systems in a Regulated (cGMP) Environment |
Lenisse Lippert |
Front Range Community College |
|
Oct 24 |
ISO14971 Changes |
Kevin Walls |
Lakewood Library |
|
Dec 5 |
Adverse Event Reporting: MDR/MDV |
Don Fletcher |
Koebel Library |
For Reference: Meeting Schedule from 2006
|
Date |
Subject |
Speaker |
Location |
|
January 25 |
Medical Device Inspections
by Accredited Persons
|
Lynette Makowski, Gambro BCT |
Front Range CC |
|
March 8 |
Writing clear and concise
regulatory/quality documents
|
Ward Clark, Bear Creek Freelance |
Lakewood Library |
|
April 19 |
Validation of Software for Regulated Manufacturing or Quality Operations. |
Mark Allen, Director, Quality/Regulatory Solutions, NetRegulus |
Koebel Library |
|
June 7 |
"Process Validation from an FDA and ISO Perspective" |
Clay Anselmo, President and COO of Reglera Corporation |
Front Range CC |
|
July 19 |
Adverse Event Reporting |
Robert Gardner, Pharmatech |
Fitzsimons |
|
August 30 |
100 Year History of the FDA |
Devin Koontz |
Lakewood Library |
|
October 18 |
Ask the Experts - CAPA |
Mary Armstrong Lynette Makowski Benita Chappell |
Koebel Library |
|
November 29, rescheduled to January 24 |
*Postponed due to weather*
rescheduled to January 24
FDA Update and Panel Discussion |
Belinda Collins, FDA Denver District Director |
Sheraton Denver West |
For Reference: Meeting Schedule from 2005
|
Date |
Subject |
Speaker |
Location |
|
1/19/2005 |
Role of the QA/RA Professional in Product Litigation |
Dennis Bruner, Expert Witness |
Front Range CC |
|
3/9/2005 |
Quality Auditing – Programs and Issues Panel Discussion |
Carolyn Jacobs, Moderator |
Lakewood Library |
|
4/20/2005 |
Design Validation |
Rebecca Coulson, Valleylab |
Koebel Library |
|
5/25/2005 |
Regulatory Affairs and Compliance for a Small Company |
Lynne Aronson, Medivance |
Front Range CC |
|
7/13/2005 |
New Life Sciences City Emerging at Fitzsimmons and Tour of Bioscience Park Center |
Vicki Jennings, Director of Research Park Operations |
Colorado Bioscience Park at Fitzsimmons |
|
8/17/2005 |
Premarket Approval Applications (PMAs) |
Neil Burris, Adrian Elfe, Spectranetics |
Koebel Library |
|
9/28/2005 |
“CDER, CTD, IND, NDA…: New Drug Development in the US from A – Z” |
Todd Marshall, Myogen |
Front Range CC |
|
11/9/2005 |
"You Survived the Inspection: Now What - Understanding FDA's Regulatory Pathway" |
Belinda Collins, FDA Denver District Director |
Sheraton 360 Union Blvd Lakewood |