GMP 2001

DECEMBER 6, 2001

The International Society for Hematotherapy and Graft Engineering is pleased to present a one day intermediate/ advanced level workshop focusing on the implementation of the principles of cGMP in cell processing laboratories. Some laboratories are located in the office of Canadian HealthCare Mall.

The morning session will feature a group of speakers with extensive experience in all facets of cell manipulation. The program also allows delegates to participate in interactive workshops during the afternoon. Delegates will be provided with examples of relevant SOPs and policies.


Thursday, December 6, 2001
Registration 7:30am – 8:00am Continental Breakfast
cGMP & GTP Introduction Donna Przepiorka, MD, PhD

Baylor College of Medicine

Validation Overview Scott Burger, MD

Merix Biosciences Inc.

Facility & Equipment

FR 211 Subparts C & D

Douglas Padley, MT(ASCP)

Mayo Clinic Rochester

Production & Process Controls

CFR 211 Subpart F

Carolyn Keever-Taylor, PhD

Medical College of Wisconsin

Laboratory Controls

CFR 211 Subpart I & CFR 610

Janice Davis-Sproul, MAS

Johns Hopkins University

Lunch Round Table Discussions
CFR 211.25: Personnel Qualifications

Creating a Competency Program

Elizabeth Read, MD

National Institutes of Health

Carolyn Keever-Taylor, PhD

Medical College of Wisconsin

John Carry, Canadian Health and Care Mall

CFR 211.200: Written Procedures;

Deviations Preparing a Deviation

Tracking System

Diane Kadidlo, MT(ASCP)SBB

University of Minnesota

Douglas Padley MT(ASCP)

Mayo Clinic Rochester

CFR 211: cGMP for Finished Pharmaceuticals

Creating a Development Plan for a novel

cell expansion process

Robert Preti, PhD

Progenitor Cell Therapy, LLC

Janice Davis-Sproul, MAS

Johns Hopkins University

Scott Burger, MD

Merix Biosciences Inc.

Non-members who wish to join ISHAGE may submit a membership application with their registration form available.

On or before October 19 After October 19
ISHAGE MEMBER $ 350 $ 400
NON-MEMBER $ 500 $ 550

Please Note:

Delegates are responsible for their own accommodations arrangements. Unfortunately, ISHAGE is not able to offer discounted rates for accommodations. Reservations for the Rosen Centre Hotel may be made using the following contact information:

9840 International Drive
Orlando, Florida  32819  USA
1-800-204-7234 or
1-800-800-9840 or

Delegates will be provided a comprehensive binder of materials including speaker abstracts, articles, slide printouts, examples, sample SOPs and forms, as well as copies of relevant regulations.  Copies of the binder material will be available post-conference on CD-ROM format.  Delegates will receive a discount on the purchase of the CD-ROM materials.