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Innovative Computerized System Validation and Auditing
Program Code:
250
Date:
Tuesday, June 25, 2013
Time:
1:45 PM to 3:15 PM
EST
CHAIR
:
Frances E. Nolan,
MBA (SCHNON), Vice President, Quality and Regulatory Affairs,
Medidata Solutions Worldwide, United States
SPEAKER
(S):
Ron Fitzmartin,
PhD,MBA (SPKAGY), Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER,
FDA, United States
Ron Fitzmartin is Sr Advisor, Office of Planning and Informatics, CDER, FDA. Ron held positions at Decision Analytics, Daiichi Sankyo, & Purdue Pharma. Degrees: PhD in statistics; Univ of Maryland, MBA; Univ of New Haven; and MS / BS - So. Conn. State Univ. DIA President, 2007-09.
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Eric Staib, MBA,MSc (SPKNON), Senior Director, IT Quality Systems, RPS, Inc., United States
Tam D. Woodrum, JD,MS (SPKNON), Executive, Software, GE Healthcare, 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.