Cloud Technology for Decision Makers: What's Real and How to Validate It
Track
:
Track 07: Processes and Technologies for Clinical Research
Program Code:
347
Date:
Wednesday, June 26, 2013
Time:
1:45 PM to 3:15 PM
EST
Location:
251
CHAIR
:
Teri E. Stokes, PhD,MS,MT (SCHNON), Director, GXP International, United States
Dr. Stokes worked 11 years as a Medical Technologist in hospital, research, and central medical laboratories. Then 16 years at Digital Equipment Corporatin (DEC). Since 1996 she has had her own computer validation consultancy GXP International. Author of 3 books, many articles. In DIA since 1982.
SPEAKER
(S):
Chris R. Dagdigian, (SPKNON), Co-Founder and Principal Consultant, BioTeam, Inc., United States
Chris is an infrastructure geek & BioTeam co-founder specializing in the applied use of high performance computing to enable and enhance scientific research in life science informatics environments.
Charles Lankford is CEO and a co-founder of PharmaSys, Inc. With headquarters in the Research Triangle Park area of North Carolina, PharmaSys provides validation and compliance services to pharmaceutical, medical device, biotech and clinical research firms.
Julia Zhang, PhD (SPKNON), Associate Director, Sanofi, United States
Dr. Zhang has worked in pharm for yrs and presented at different confs as keynote/invited speaker. Her expertise focuses in: project mgt; regulatory submissions; stds development and implementation; external and internal collaborations; bioinformatics, clinical trial data mgt and operations, etc.
Description
The goal of this session is to help people make practical, informed decisions based on what cloud technology options exist today and how to assess their pros and cons for productivity and regulatory compliance in clinical trials. It is important to use this technology in a responsible way, and speakers will share their experience with system validation and data validation in the cloud. The presentations will identify and discuss the key factors and concepts required to make defensible decisions about using cloud technology for regulated purposes.