Developing, Implementing and Maintaining a Functional GTP, GMP (or Combination) Cellular Therapy Program
Program Code: 122-QE
Saturday, October 15, 2005
2:00 PM to 5:30 PM (ET)

MODERATOR
J. Wade Atkins, CQA(ASQ), MS, MT(ASCP)SBB, National Institutes of Health
Cindy Elliott, MT, HP(ASCP), CQA(ASQ), CT Auditing & Compliance Services LLC

SPEAKERS
Ellen F. Lazarus, MD, CAPT, USPHS, Food and Drug Adminstration
Hanh Khuu, MD, National Institutes of Health
Karen J. Edward, BS, MT(ASCP), Advanced Cell and Gene Therapy
Florinna Dekovic, CLS, MT (ASCP) BB, CQA (ASQ), UCSF GMP Lab
Jocelyn Cruz, MT(ASCP)SBB, University of California San Francisco-Medical Cen
Jacque Tagliere, MT(ASCP)SBB, Children's Hospital Los Angeles

DESCRIPTION
Are you trying to wade through the final GTP rules recently published by FDA? Are you struggling with developing, implementing and maintaining a quality program in your setting? Are there times when you think there is no right answer with what to do if you have a non-conforming product? You are not alone! This workshop will review FDA expectations for these programs and cover ways to implement a functional quality program. The panel discussion will have representatives from GTP, GMP, GTP/GMP and Collections programs that will present case studies for interactive resolutions.