Cell Therapy

Part 1.&nbsp;&nbsp;&nbsp;&nbsp; Regulatory<p>1.&nbsp; Regulation of Cell Therapy in the United States&nbsp;</p><p>2.&nbsp; &nbsp;Regulatory Landscape and Emerging Trends In Advanced Therapies Manufacturing: An EU Perspective&nbsp;</p><p>3.&nbsp; &nbsp;Australian Cellular Therapy Regulations&nbsp;</p><p>4.&nbsp; &nbsp;Landscape for Regenerative Medicine Manufacturing in Japan&nbsp;</p><p>5.&nbsp; &nbsp;GLP Regulations for Non-clinical studies&nbsp;</p><p>6.&nbsp; Ethical Considerations in Cell Therapy&nbsp;</p><p>7.&nbsp; Investigational New Drug Applications for Cell Therapy Products</p><p>8.&nbsp; &nbsp;FDA Inspections&nbsp;</p><p>9.&nbsp; &nbsp;Commercialization of Investigational Cell Therapy Products&nbsp;</p><p>Part 2&nbsp; &nbsp;Quality Systems</p><p>10.&nbsp; The Meaning of Quality&nbsp;</p><p>11.&nbsp; &nbsp;Development and Maintenance of a Quality Program</p><p>12.&nbsp; &nbsp;Quality Control of Cellular Therapy Products and Viral Vectors&nbsp;</p><p>13.&nbsp; &nbsp;Quality Management Software – Q-Pulse&nbsp;</p><p>14.&nbsp; &nbsp;Selection of Contract Manufacturing and Testing Organizations&nbsp;</p><p>Part 3&nbsp; &nbsp; &nbsp;Facility Design</p><p>15.&nbsp; &nbsp;Introduction: Facility Design&nbsp;</p><p>16.&nbsp; &nbsp;PACT CPFs - Examples Describing Different Cell Processing Facility Designs</p><p>17. Design and Operation of a Multiuse GMP Facility at the City of Hope&nbsp;</p><p>18. Design and Operation of a Multiuse GMP Facility at the University of Miami&nbsp;</p><p>19.&nbsp; &nbsp;Design of a New Academic GMP Facility for Today and Beyond at the Dana-Farber Cancer Institute</p><p>20.&nbsp; Design and Licensure of an American Cord Blood Bank&nbsp;</p><p>21.&nbsp; &nbsp;Indiana University Vector Production Facility (IUVPF)&nbsp;</p><p>22.&nbsp; &nbsp;Qualification and Commissioning of a New GMP Facility&nbsp;</p><p>Part 4&nbsp; &nbsp;&nbsp;Facility Infrastructure</p><p>23.&nbsp; &nbsp;Environmental Monitoring&nbsp;</p><p>24.&nbsp; &nbsp;GMP Facility Cleaning and Maintenance&nbsp;</p><p>25.&nbsp; GMP Documentation&nbsp;</p><p>26.&nbsp; &nbsp;Process Validation&nbsp;</p><p>27.&nbsp; &nbsp;Equipment Qualification&nbsp;</p><p>28.&nbsp; Vendor Qualification and Supply Management&nbsp;</p><p>29.&nbsp; Staffing, Training and Competency&nbsp;</p><p>Part 5&nbsp; &nbsp;&nbsp;Product Management</p><p>30.&nbsp; &nbsp;Product Accessioning, Tracing and Tracking&nbsp;</p><p>31.&nbsp; &nbsp;ISBT 128 in Labeling of Cellular Therapy Products&nbsp;</p><p>32.&nbsp; &nbsp;Product Processing, Manufacturing and Administration&nbsp;</p><p>33.&nbsp; &nbsp;Transport and Shipment of Cellular and Gene Therapy Products&nbsp;</p><p>34.&nbsp; &nbsp;&nbsp;Regenerative Medicine: The Newest Cellular Therapy</p><p>35.&nbsp; &nbsp; &nbsp;Cellular Therapy Applications for COVID-19&nbsp;</p><p>Part 6&nbsp; &nbsp;&nbsp;Professional Standards and Support Organizations</p><p>36.&nbsp; &nbsp;Professional Standards for Cellular Therapy: The Foundation for the Accreditation of Cellular Therapy (FACT)&nbsp;</p><p>37.&nbsp; &nbsp;AABB Cell Therapy Standards</p><p>38.&nbsp; USP Standards for Cell-based Therapies</p><p>39.&nbsp; &nbsp;The Role of the National Institute of Standards Measurement Assurance for Cell Therapies</p><p>40.&nbsp; National Science Foundation Engineering Research Center for Cell Manufacturing Technologies (CMaT)&nbsp;</p><p>41.&nbsp; Financial Considerations for Academic GMP Facilities&nbsp;</p><p>42.&nbsp; Governmental Support Opportunities for Cellular & Gene Therapies in the United States&nbsp;</p>