Innovative Computerized System Validation and Auditing

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 25, 1:45PM - 3:15PM

Session Number:
250

Room Number:
251

Level:
Intermediate

Type:
Forum

Title:
Innovative Computerized System Validation and Auditing

Chair(s):
Frances E. Nolan, MBA
Vice President, Quality and Regulatory Affairs
Medidata Solutions Worldwide, United States

Description:
Panel participants and attendees will discuss how suppliers, users and regulators can leverage more modern and innovative techniques for developing, validating and deploying solutions.

Learning Objective(s):
Identify the challenges and opportunities for improving the effectiveness and efficiency of validation; Describe the challenges and opportunities for more effectively and efficiently conducting and hosting audits.

Presentation(s) & Speaker(s):
Panelist
Ron Fitzmartin, PhD,MBA
Senior Advisor, Office of Planning and Informatics, CDER
FDA, United States

Panelist
Eric Staib, MBA,MSc
Senior Director, IT Quality Systems
RPS, Inc., United States

Panelist
Tam D. Woodrum, JD,MS
Executive, Software
GE Healthcare, United States