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Preventing the Validation Vortex

ASQ Biomedical Division

Monday, October 13, 2014 at 8:15 AM - Tuesday, October 14, 2014 at 4:45 PM (CDT)

Preventing the Validation Vortex

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Vortex

 

 


Join with Ricki Chase, Chicago FDA Director of Investigations, and industry experts in two days of ways to avoid the Validation Vortex.

Only $599 for two days of information

Make your hotel reservation now

http://hiltongardeninn.hilton.com/en/gi/groups/personalized/O/ORDCHGI-VV1-20141012/index.jhtml?WT.mc_id=POG

1.6 CEU/RU for this event

October 13, Monday, Day 1

 

Welcome and Introduction

Beth Kelly and Pam Goldstein, Program Co-Chairs

8:45 – 9:00 am

Keynote Speaker Importance of Validation and Warning Letters

Ricki Chase, FDA

9:00 – 9:45 am

Process Validation Overview and Planning  

Teresa Cherry, Iradimed Corporation

9:45 – 10:30 am

 

Break                                                                                                  10:30 – 10:45 am

 

Process Validation Elements

Darren Schurig, Alcon

10:45 – 11:45 pm

Process Risk Management

Barry Craner, Stellartech Research Corporation

11:45 – 12:30 am

 

Lunch                                                                                                  12:30 – 1:30 pm

 

Process Risk Management Workshop

Barry Craner, Stellartech Research Corporation

1:30 – 2:30 pm

 

Break                                                                                                   2:30 – 2:45 pm

 

Process and Regulated Processes Software Validation Elements

Arta Doci, Quality Arete Group

2:45 – 3:45 pm

Controlled Environment Qualification/Validation

Teresa Cherry, Iradimed Corporation

3:45 – 4:30 pm

 Q & A               and review of ‘parking lot’                                                          4:30 – 4:45pm

See Day 2 for CEU/RU credit

October 14, Tuesday, Day 2

 

Review of Day 1 Questions

Richard Vincins, ASQ Biomedical Division Chair

8:30 – 8:45 am

Statistical Tools for Validation

Steven Walfish, Becton-Dickenson

8:45 – 9:30 am

Design Verification/Validation

Scott Blood, NinePoint Medical

9:30 –10:15 am

 

Break                                                                                                   10:15 –10:30 am

 

Risk Management input to Design Validation  

Barry Craner, Stellartech Research Corporation

10:30 – 11:30 am

Human Factors/Usability testing

Sara Waxberg, Philips Healthcare

11:30 – 12:15 pm

 

Lunch                                                                                                  12:15 – 1:15 pm

 

Workshop Validation Planning

Pamela Goldstein, Moderator

1:15 – 2:15 pm

Handling Change

Jim Shore, Quality Lean Solutions

2:15 – 3:00 pm

 

Break                                                                                                   3:00 –3:15 pm

 

Panel Discussion

Beth Kelly and Pam Goldstein, Moderators

3:15 – 4:30 pm

 

 

 

1.6 CEU/RU awarded to ____________________________________________

 

By: Richard Vincins                                                      Division Chair

 

Only $599 for two days of information

Make your hotel reservation now

http://hiltongardeninn.hilton.com/en/gi/groups/personalized/O/ORDCHGI-VV1-20141012/index.jhtml?WT.mc_id=POG

1.6 CEU/RU for this event.

Have questions about Preventing the Validation Vortex? Contact ASQ Biomedical Division

When & Where


Hilton Garden Inn Chicago OHare Airport
2930 S River Rd
Des Plaines, IL 60018

Monday, October 13, 2014 at 8:15 AM - Tuesday, October 14, 2014 at 4:45 PM (CDT)


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