| Sponsored by the ISCT North American Legal and Regulatory Affairs Committee December 16, 2009 2pm ET Moderator: Fran Rabe, Director of Quality Assurance, University of Minnesota Molecular and Cellular Therapeutics Speakers: - Fran Rabe, Director of Quality Assurance, University of Minnesota Molecular and Cellular Therapeutics
- Lisa Phillips-Johnson, Director of Regulatory Compliance, National Marrow Donor Program
Objectives: - Docket Presentation:
- High and Low Points of the FDA’s new Guidance Documents on unrelated allogeneic cord blood licensure and IND
- Basics of unrelated allogeneic cord blood licensure. Who, What, Why and How
- The distribution of cord blood when you don’t meet licensure requirements
- Discussion and Comments
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| Sponsored by the ISCT Lab Practices Committee November 18, 2009 12 pm ET Speakers: - Federico Rodriguez, MT, (ASCP), SBB, Blood Bank Supervisor, Yuma Regional Medical Center, Yuma, AZ; Independent International Consultant for Cellular Therapy and Blood Bank Services
- Aisha Khan, M.Sc., MBA, Director of Operations, Islet Cell Processing Facility,cGMP
Cell Transplant Center/ Diabetes Research Institute
Objectives: - Mention the most recent regulatory requirements for sterility testing on Cellular Therapy products.
- Outline different methods to perform the testing.
- Describe validation methods for both manual and automated procedures.
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| Sponsored by the ISCT North American Legal and Regulatory Affairs Committee October 21, 2009 12 pm ET Speakers: - Karen Edward, BS, MT(ASCP), Advanced Cell & Gene Therapy
- Mary Coon, BS, CQA, Dendreon Corporation
- Elizabeth Konecki, MS, MT(ASCP), SBB, Wilford Hall Medical Center
Objectives: An FDA inspection can be a nightmare costing your organization money, time and reputation, or it can be an opportunity to make a positive impression with regulators and improve your quality systems. Webinar attendees will learn how to prepare, manage and successfully complete GMP/GTP regulatory inspections. The speakers will present their real-life experiences in handling FDA inspections in their own facilities.
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| Sponsored by the ISCT North American Legal and Regulatory Affairs Committee September 9, 2009 12pm EDT
Speakers: - Scott Burger, MD, Principal, Advanced Cell & Gene Therapy
- Aby Mathew, PhD, Senior Director of Strategic Relations and Senior Scientist, BioLife Solutions
Objectives: - Understand requirements for stability testing in cell therapy, and how to establish a stability testing program
- Understand methods and technologies for optimizing stability and preservation of cells, tissues, and cell therapy products
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| Sponsored by the ISCT North American Legal and Regulatory Affairs Committee June 24, 2009 12 pm EDT Speakers: - Asiya Imam, PhD, CQA Senior Manager, Quality System / Advanced Bioprocessing BD Biosciences
- Olive Sturtevant, MHP, MT(ASCP) SBB/SLS, Quality Assurance Manager, Dana-Farber Cancer Institute
Objectives: - Utilizing tools of risk management from the device world and using them to develop an approach for cellular therapeutic products
- Root cause analysis
- Prospective risk assessment for program planning
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| Sponsored by the ISCT North American Legal and Regulatory Affairs Committee April 22, 2009 12 pm EDT Speakers: - William E. Janssen, Ph.D,Moffitt Cancer Center, Tampa, FL
- Scott R. Burger, M.D., Advanced Cell & Gene Therapy, LLC, Chapel Hill, NC
Objectives: - Understanding the concept of the batch process manufacturing versus continuous process manufacturing, and how cell therapies production fits the batch process model
- Understanding the concept and role of the batch process record (BPR) from the standpoint of it’s roots in manufacturing, particularly of pharmaceuticals
- Knowing the requirements of the FDA with respect to the BPR, and how they can serve as guidance for creating a facilities own BPR. Particularly:
- Master process record
- Working batch process record
- Master process record
- Working batch process record
- Master process record
- Working batch process record
- Establishing a minimum content for cell therapies BPR
- Understanding the benefits and requirements that pertain to electronic BPR
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| Sponsored by the ISCT Lab Practices Committee March 25, 2009 12pm ET Speakers: - Elizabeth Konecki, MS, MT(ASCP), SBB, Wilford Hall Medical Center
- Olive Sturtevant, MHP, MT(ASCP) SBB/SLS, Quality Assurance Manager, Dana-Farber Cancer Institute
Objectives: - Outline the components of process validation.
- Apply the components of validation to prospective and retrospective processes.
- Include specific examples of process validation for cellular therapy applications.
- Address how to determine the appropriate or significant number of validation trials for a given process.
- Discuss challenges presented by staffing/smaller laboratories.
- Discuss how to handle validation failures or non-conforming products for "re-validation”.
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| Sponsored by the ISCT Lab Practices Committee February 18, 2009 12pm ET Speakers: - Lizabeth Cardwell, MT(ASCP), RAC, MBA, Principle Consultant, Compliance Consulting, WA
- Karen Edward, BS, Advanced Cell and Gene Therapy, NY
Objectives: - Validation of Equipment - Lizabeth Cardwell
- Provide an overview of equipment validation.
- Outline the components of a validation plan. Provide a specific example of an equipment validation.
- Qualification of Reagents - Karen Edward
- Provide an overview of reagent qualification.
- Outline the components of reagent qualification.
- Provide a specific example of a reagent validation.
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