ISCT Webinars from 2009

Distribution of Unrelated Manipulated Cord Blood in or to the U.S. after October 20, 2011, a Domestic and International Perspective

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:

  1. 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
  2. Discussion and Comments
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Sterility Testing for Cellular Therapy Product

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:

  1. Mention the most recent regulatory requirements for sterility testing on Cellular Therapy products.
  2. Outline different methods to perform the testing.
  3. Describe validation methods for both manual and automated procedures.


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FDA Inspections for Cell Therapy Products from the Perspective of Hospitals and Industry

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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Stability Testing and Optimization - Considerations for Cell Therapy Products

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:

  1. Understand requirements for stability testing in cell therapy, and how to establish a stability testing program
  2. Understand methods and technologies for optimizing stability and preservation of cells, tissues, and cell therapy products


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Risk Management Approach for Cell Therapeutics with Case Studies

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:

  1. Utilizing tools of risk management from the device world and using them to develop an approach for cellular therapeutic products
  2. Root cause analysis
  3. Prospective risk assessment for program planning

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Batch Records for Cell Therapy Products

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:

  1. Understanding the concept of the batch process manufacturing versus continuous process manufacturing, and how cell therapies production fits the batch process model
  2. Understanding the concept and role of the batch process record (BPR) from the standpoint of it’s roots in manufacturing, particularly of pharmaceuticals
  3. 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
  4. Establishing a minimum content for cell therapies BPR
  5. Understanding the benefits and requirements that pertain to electronic BPR

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(Part 2): Validation of Processes: Retrospective and Prospective

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:

  1. Outline the components of process validation.
  2. Apply the components of validation to prospective and retrospective processes.
    • Include specific examples of process validation for cellular therapy applications.
  3. 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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(Part 1): Validation and Qualification of Equipment and Reagents

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:

  1. 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.
  2. Qualification of Reagents - Karen Edward
    • Provide an overview of reagent qualification.
  3. Outline the components of reagent qualification.
  4. Provide a specific example of a reagent validation.

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