Validation Rules and Regulations: How Do They Apply to Me?
Program Code: 9123-QE-CT
Saturday, October 24, 2009
2:00 PM to 3:30 PM (ET)

MODERATOR
Ellen Areman, MS, SBB(ASCP), Ellen Areman Consulting, LLC

SPEAKERS
Lynn O'Donnell, PhD, The Ohio State University, James Cancer Hospital
Michele Sugrue, MS, MT(ASCP)SBB, University of Florida
Lizabeth Cardwell, MBA, MT(ASCP), Compliance Consulting

DESCRIPTION
This session will describe the requirements for validation, verification and qualification of cell therapy processes, test methods and equipment. Speakers will describe approaches to validation based on the applicable regulatory requirements for different types of cell therapy products.