Challenges Associated with Implementing a New Database / Data Management System

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Wednesday, September 22, 2010
1pm EDT-- NEW TIME

Speaker:

Richard C. Meagher, PhD, Director, Cell Therapy Processing Facility, Northwestern University

Topic Objectives:
To give insight / provide information and discuss the following common challenges regarding implementation of a data management system for a transplantation program:
•    Understand institutional challenges involved in implementing a data management system
•    Program needs: A whole system or a partial system – Does it matter?
•    Identifying who needs to be involved, and at what stage of implementation
•    Developing User Requirements – What does it mean?
•    When to involve Information Technology/Services

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Business and Quality Agreements for the Cell Therapy Facility

Wednesday, October 27, 2010
12pm EDT

Speakers:

Karen Edward, BS, MT (ASCP), Advanced Cell & Gene Therapy
Lizabeth J. Cardwell, MT(ASCP), MBA, RAC, Compliance Consulting

Synopsis:

Do you struggle with putting agreements in place in your facility? Do you know when you need to establish formal agreements and with whom? Do you know what content to include that’s mutually beneficial for your material and service providers and your organization? If you have often asked yourself these questions then this is the webinar for you. We will present the differences between business and quality agreements and how they are linked, and provide practical guidance for drafting these documents. Having current agreements in place protects your organization, is good business, and is important to monitoring the overall quality of materials and services so critical to the manufacturing of your product.

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GXP Requirements in Translational Research – From Bench to Bedside

Wednesday November 10, 2010
12pm ET

Speaker: Adrian Gee, MIBiol, PhD, Director, Clinical Applications, Center for Cell and Gene Therapy, Baylor College of Medicine

Learning Objectives

1. Gain an understanding of the regulatory continuum covering transition of a cellular therapy from research into clinical trial
2. Understand the basic components of Good Laboratory, Manufacturing and Clinical Practices and where to find them
3. Learn the role of the GMP staff in interfacing with the basic researchers and the clinician to accelerate the transition process
4. Appreciate the non-manufacturing tasks that will fall to the GMP staff when transitioning  a therapy from research into clinical practice
5. Understand the role of the FDA in regulating this area and in enforcing the regulations

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Auditing: Tips, Tools and Techniques

Wednesday, June 9, 2010
12pm EST

Speaker:

J. Wade Atkins, MS, MT(ASCP)SBB, Quality Specialist, National Institute of Health

Objectives:

After the webinar the participant should be able to:

1)    Discuss how to plan an audit.

2)    List the traits and attributes of a qualified auditor

3)    Describe methods and ways to conduct audits that are not distracting to working employees.

4)    List the elements to include in an audit report.

J. Wade Atkins is a Quality Assurance Specialist for the Department of Transfusion Medicine in the Clinical Center of the National Institutes of Health and has been in that role for the last 8 years. .  Wade has over 20 years of experience in blood banking and the last 12 have been in Quality Assurance.  He is an American Society of Quality Certified Quality Auditor,(ASQ, CQA).  On average he conducts 10 -15 audits per year.

Transportation of HCT/Ps from UCB, BM and PBSC

March 10, 2010
12pm EST

Speakers:

Karen Nichols, VP, Regulatory Affairs and Quality Systems, Viacell Inc.

Lezlie Hynes, NMDP Manager of Quality Assurance

This presentation will review basic definitions, differences in transportation models, and considerations for international versus domestic shipments, providing the basis for discussion of defining the real value of a secure supply chain – optimal collection of raw material from the field through delivery of quality final product to the site of use.

ISBT 128 Labeling for Cellular Therapy

Organized by the Laboratory Practices Committee
February 17, 2010
12pm ET

Chair: Leigh Sims Poston, BSc
Speakers:

Chao-Yong Lee, BSc, Data Manager of the Leukemia/Bone Marrow Transplant Program of BC
Giovanna Cameron, RT, Section Head, Clinical Cell Therapy Laboratory
BC Cancer Agency
Pat Distler, MS, MT(ASCP)SBB, Technical Director, ICCBBA

Webinar Objectives:

• Provide participants with information regarding the current status of the global initiative for ISBT 128 labeling of cellular therapy products.
• Provide participants with system and implementation insight from a facility with one year of operational experience.
• Focused discussion of overcoming the hurdles of implementing ISBT 128 labeling for a multi-site BMT program.
• Describe and review labeling system design process, implementation and validation.
• Discuss current issues and challenges.