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.
PROGRAM
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.
REGISTRATION | ||
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
407-996-9840
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.