Session Information
AABB Annual Meeting and CTTXPO 2013
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The IND Submission Process and the Role of the Cell Therapy Laboratory in the Creation of the Chemistry, Manufacturing and Control (CMC) Documentation
Track
:
QE - Quality Education
Program Code:
9224-QE-CT
Date:
Sunday, October 13, 2013
Time:
2:00 PM to 3:30 PM
EST
Location:
702/704
DIRECTOR
:
Mr. F. Enrique Alvarez, BS, MLS(ASCP)CM, CQA(ASQ), Assistant Director, Cell Therapy Laboratory, UT MD Anderson Cancer Center
MODERATOR
:
Mr. F. Enrique Alvarez, BS, MLS(ASCP)CM, CQA(ASQ), Assistant Director, Cell Therapy Laboratory, UT MD Anderson Cancer Center
SPEAKER
(S):
Dr. Eric Dollins
Claudia Garza-Gonzalez, BS, MT(ASCP), Quality Assurance Specialist, MD Anderson Cancer Center
Sean O'Connor, PhD, RAC, Coordinator, Regulatory Compliance, MD Anderson Cancer Center, Department of Stem Cell Transplantation and Cellular Therapy
Description
The Investigational New Drug/Device (IND) submission process is a structured journey that can be difficult if not well understood. With increasing participation of cellular therapy laboratories in IND trials, the nuances of creating a Chemistry, Manufacturing and Controls (CMC) document or a Certificate of Analysis (CoA) can be a daunting task. This session will review the IND submission process, explain the requirements and creation of a CMC document and describe the elements of a COA for the release of final products for infusion. Examples of proper documentation will be shared with the audience to elicit participation and share experiences during this session.
- Discuss the generation of CMC documentation in support of cell therapy-related IND trials.
- Review the IND submission process for cellular therapy products.
- Review the process for releasing final product(s) under an IND-regulated protocol, and using a CoA.
| CE Category | CE Value |
|---|---|
| California Clinical Laboratory Personnel | 1.5 |
| California Nurse | 1.8 |
| Florida Laboratory Personnel | 1.8 |
| General Attendee | 1.5 |
| Physician | 1.5 |
Please note: Continuing education (CE) credit is available for online offerings only. Individuals that purchase CD-ROMs will not receive CE credit for the programs they view.
Audio Synchronized to PowerPoint
(Code: 9224-QE-CTAM/9224-QE-CTA/9224-QE-CTM/9224-QE-CT)
Annual Meeting Attendee/AABB Member:$25 USD
Annual Meeting Attendee/Non AABB Member:$40 USD
Non-Attendee/AABB Member:$40 USD
Non-Attendee/Non AABB Member $50 USD - Your Price
This session is a part of:
This session is a part of:
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