2016 Special Symposium:

A Changing Future for QA Professionals 

Friday, 30 September 2016, 8:00 AM – 5:00 PM

Cosponsored by the Pacific Regional Chapter of the Society of Quality Assurance

The Symposium will be held in conjunction with the 2016 Fall Quality College - learn more!

Register Online Today!

RQAP re-registration units: 2.00 GCP/GLP
NOTE: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

The Special Symposium will now feature discussion of the
Notice of Proposed Rule Making (NPRM) to amend the FDA GLPs.

Register for the Symposium and have your voice heard and included in the
SQA comments to the Agency!

Prices - 

  • Before 1 September 2016: Member Rate $350, Non-member Rate $415
  • After 1 September 2016: Member Rate $375, Non-member Rate $445

The topics of this Symposium will focus on, but are not limited to, what is important in today's QA world: 
  • Data Integrity
  • QMS Concepts Across GxPs
  • QASR Process (data quality review of submissions) used at ONADE
  • Predicate Rule - discussion and how it has changed over the years
    Now featuring discussion of the Notice of Proposed Rule Making (NPRM) to amend the FDA GLPs!

Preliminary Agenda

8:00 - 8:05 AM

Welcome and Overview

Hector Gamboa

8:05 - 9:05 AM

Risk Assessment

Jamie Colgin

9:05 - 10:05 AM

Data Integrity

Joe Franchetti

10:05 - 10:15 AM

Break - 10 minutes

10:15 - 11:30 AM

QASR Process used at ONADE

Debi Garvin

11:30 AM - 12:30 PM


12:30 - 1:15 PM   

QMS Concepts Across GxPs

Paula Parsons

1:15 - 2:30 PM

FDA BIMO Specialization Alignment Program

Victor Meo

2:30 - 2:40 PM


2:40 - 5:00 PM

GLP NPRM - Roundtable Discussion

Greg Furrow

5:15 PM*

Questions, Discussion and Wrap Up

*The discussion is scheduled last to take advantage of covering all topics and keeping the room into the evening for full discussion of the NPRM. Be sure to plan your travel accordingly.

Register Online Today!

PDF Registration Form

SQA September Quality College & Special Symposium

26-30 September 2016
Seattle, Washington, USA

The September 2016 Quality College and Special Symposium will be held at: 
DoubleTree Suites, Seattle Airport/Southcenter
16500 Southcenter Parkway, Seattle, WA 98188
Tel: +1 800.222.8733

Special SQA room rate: $189.00

Reserve your room today!


Cosponsored by PRCSQA