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Products are filtered by different dates, depending on the combination of live and on-demand components that they contain, and on whether any live components are over or not.
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  • LIVE EVENT!
    Includes Credits Includes a Live In-Person Event on 11-06-2024 at 10:00 AM (CST)

    The 12th Quality Management Webinar Series theme is Embrace Change: Growing Your Cellular Therapy Services. Over two years, each webinar will focus on a separate step of implementing a new service and/or product into a program through the lens of experienced quality personnel. Purchase the entire live QM Series 12 Part 2 bundle here: https://learn.factglobal.org/p...

    Part 1 featured four webinars throughout 2023 and the beginning of 2024. You may find it helpful to review the concepts from Part 1 before diving into this continuation! You can purchase the QM Series 12 Part 1 On-Demand bundle here: https://learn.factglobal.org/p...

    At the conclusion of this live activity, participants will be able to:

    1. Apply examples of methods used to implement a new service.

    2. Select practices to assess the effectiveness of a new service.

    3. Formulate examples of an interruption of operations plan.

    Wade Atkins, MS, MT(ASCP), SBB, CQA

    Sr. Quality Assurance and Regulatory Affairs Specialist

    National Institutes of Health

    HOST

    Nothing to disclose.

    Bernadette Mestichelli, MBA, ASQ

    Director of Quality Assurance

    American Red Cross

    Bernadette Mestichelli, MBA, ASQ, is the Director of Quality Assurance for the American Red Cross. She obtained a Bachelor of Science in Medical Technology from the Philadelphia College of Pharmacy and Science, an MBA in management and operations at the New York Institute of Technology, a Manager of Quality/Organizational Excellence certification through the American Society for Quality, and a certification as a Medical Technologist through the American Society of Clinical Pathologists.

    Nothing to disclose.

    Kerri Hill, BSN, RN, OCN

    Quality Management Director

    UAMS Cancer Institute

    Kerri Hill, BSN, RN, OCN, serves as the Director of Quality for the University of Arkansas for Medical Sciences (UAMS) Cancer Institute transplant and cellular therapy program with 12 years of experience in this role and 26 total years of nursing experience in the field.  Her experience includes transplant and cellular therapy delivery in the inpatient and ambulatory settings. She coordinated multidisciplinary teams in expanding the autologous transplant program to include allogeneic transplants in 2015, onboarding five commercial CAR T products with three pharma groups beginning in 2019, and achieving the corresponding FACT Accreditations.

    Nothing to disclose.

    Debbie Nennstiel, MBA

    Director of Quality Assurance

    Blood Assurance

    Nothing to disclose.

    Credit Designations Pending Approval.

    • Register
      • Applicant - $100
      • Auditor - Free!
      • Committee Member - Free!
      • Consultant - Free!
      • FACT Staff - Free!
      • Inspector - Free!
      • Inspector Trainee - Free!
      • Non-member - $100
      • Industry Representative - $200
      • Fellow - $50
    • More Information
  • NEW! REGISTER NOW!!
    Includes Credits Includes Multiple Live Events. The next is on 10-01-2024 at 7:00 AM (CDT)

    This interactive workshop is designed to describe FACT's Standards and accreditation process in an engaging format facilitated by experienced FACT instructors. The workshop will include case studies and opportunities to discuss real-life scenarios with your colleagues. Presenters will discuss requirements and expectations for accreditation, how to position your organization to pursue accreditation, methods for maintaining accreditation readiness, and avoiding and correcting common citations. Additional discussion areas include improving quality in cord blood banking with FACT Accreditation, quality components of a successful stability program, and developing and assessing a quality management plan.

    HOST: AA

    Host AA Title

    Host AA Organization

    Host & Topics: Welcome & Q&A Moderator

    Host Bio

    No disclosures.

    Phyllis I. Warkentin, MD

    Chief Medical Officer

    FACT

    Topic: Overview of the FACT Accreditation Process

    Dr. Phyllis I. Warkentin is a founding member of FACT and has been serving as a board member and chief medical officer since the organization’s inception. In addition to her work with FACT, Dr. Warkentin has been the director of the unrelated bone marrow transplantation program at the University of Nebraska Medical Center since 1988 and a professor of pediatrics and pathology/microbiology at the University of Nebraska Medical Center since 1994. She attended medical school at the University of Minnesota, where she subsequently completed a residency in pediatrics and fellowships in pediatric hematology/oncology and blood banking.

    No Disclosures

    Speaker A

    Speaker AA Title

    Speaker AA Organization

    Topic: FACT Matters: Improving Quality in Cord Blood Banking with FACT Accreditation

    No disclosures.

    Roger Horton, PhD

    Cord Blood Bank Director

    The Anthony Nolan Cord Blood Bank

    Topic: Key to Compliance Application Success

    Roger Horton is the Director of the Anthony Nolan Cord Blood Bank and Cell and Gene Therapy Clinical Delivery Lead at the Anthony Nolan Cell Therapy Centre in Nottingham, UK. He also acts as the designated individual for the Human Tissue Authority, which is the UK regulator. He has been a FACT Cord Blood Bank Inspector since 2016. He serves on several committees, including the FACT Cord Blood Standards Committee and the Cord Blood Association Education Committee, and is part of the WMDA Cord Blood working group. He has more than 12 years of experience in the field of cord blood, stem cells, cellular therapy, and leukemia and, as part of the Cord Support Programme in the UK, is passionate about promoting best practices in the search, selection, manufacture, and application of cord blood in both transplant and cellular therapy applications.

    No Disclosures

    Speaker B

    Speaker BB Title

    Speaker BB Organization

    Topic: What to Expect During the Inspection

    No disclosures.

    Speaker CC

    Speaker CC Title

    Speaker CC Organization

    Topic: Panel Discussion: Three Approaches to Meeting Standards

    Nothing to disclose.

    Speaker D

    Speaker DD Title

    Speaker DD Organization

    Topic: Panel Discussion: Three Approaches to Meeting Standards

    No disclosures.

    Speaker E

    Speaker EE Title

    Speaker EE Organization

    Topic: Panel Discussion: Three Approaches to Meeting Standards

    No disclosures.

    Speaker F

    Speaker FF Title

    Speaker FF Organization

    Topic: Correction of Deficiencies

    No disclosures.

    Linda Peltier, PhD, RN, CABP

    Laboratory Manager

    Cellular Therapy Laboratory RI-MUHC

    HostTopic: Developing & Assessing a Quality Management Plan

    Linda Peltier is a critical care nurse with a Doctorate in Experimental Medicine. After setting up the clinical component and the Héma-Québec public cord blood bank laboratory, she established the first clinical-research cord blood bank in Canada at the McGill University Health Center (MUHC). She developed a quality management program to ensure the MUHC Stem Cell Program accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT) and Health Canada in 2007 and 2010. FACT Inspector for over 13 years, she opened the Cellular Therapy Laboratory at the RI-MUHC, offering consultation to researchers translating fundamental research projects into pre-clinical, phase I and II clinical trials. The CTL team collects, processes, preserves, and infuses different types of cells, ranging from mesenchymal stem cells to CAR-T, NK, CAR-NK, T cells, monocytes, and dendritic for treatments or therapies against cancers or other diseases.

    No Disclosures

    Annette Trickett, PhD

    Processing Facility Director

    Transplant and Cellular Therapies Program, Kids Cancer Centre, Sydney Children's Hospital

    Topic: Quality Components of a Successful Stability Program

    Bio Pending

    Speaker GG

    Speaker GG Title

    Speaker G Organization

    Topic: Maintaining FACT Readiness w/Activity: Strategies to Maintain FACT Readiness

    No disclosures.

    image
    This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Illinois State Medical Society (ISMS) through the joint providership of Edward-Elmhurst Health and FACT. Edward-Elmhurst Health is accredited by ISMS to provide continuing medical education for physicians. This live activity is designated for a maximum of 8.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
    • Register
      • Applicant - $650
      • Auditor - Free!
      • Committee Member - Free!
      • Consultant - Free!
      • FACT Staff - Free!
      • Inspector - Free!
      • Inspector Trainee - Free!
      • Non-member - $650
      • Industry Representative - $1,000
      • Fellow - $300
    • More Information
  • LIVE EVENT!
    Includes Credits Includes a Live In-Person Event on 09-18-2024 at 10:00 AM (CDT)

    The 12th Quality Management Webinar Series theme is Embrace Change: Growing Your Cellular Therapy Services. Over two years, each webinar will focus on a separate step of implementing a new service and/or product into a program through the lens of experienced quality personnel. Purchase the entire live QM Series 12 Part 2 bundle here: https://learn.factglobal.org/p...

    Part 1 featured four webinars throughout 2023 and the beginning of 2024. You may find it helpful to review the concepts from Part 1 before diving into this continuation! You can purchase the QM Series 12 Part 1 On-Demand bundle here: https://learn.factglobal.org/p...

    At the conclusion of this live activity, participants will be able to:

    1. Identify types of interruptions to operations.

    2. Describe possible responses to interruption of operations based on varied scenarios.

    3. Develop an interruption of operations plan.

    Cynthia Morris, MSN, RN, CPHQ

    Program Manager Transplant Quality

    St. Jude Children's Research Hospital Department of Bone Marrow Transplantation and Cellular Therapy

    Cynthia Morris, MSN, RN CPHQ, has been in the field of HCT since 2000 and in HCT Quality since 2007. She is the Transplant Quality Program Manager at St. Jude Children's Research Hospital and has led 5 successful FACT inspections at St. Jude, including IEC Accreditation. Her main responsibilities include overseeing the quality program and focusing on the clinical program and Marrow Facility.  Cindy is a current member of the FACT Quality Management Committee.

    Nothing to disclose.

    Daniel Kota

    Director, cGMP Cell Therapy Laboratory Core

    Baylor College of Medicine, Stem Cell Transplant Program, Texas Children's Hospital and Houston Methodist Hospital

    Daniel J. Kota, PhD is a Director of cGMP Cell Therapy Laboratory Core at Baylor College of Medicine, Stem Cell Transplant Program. As a native of Brazil, Kota received his PhD in medical sciences, completed his postdoctoral training in neurotrauma, and ran a research program as faculty, unlocking the therapeutic properties of adult stem cells across the USA at Burnham Institute (CA), Tulane University (LA), Texas A&M University, University of Texas (TX), and Sanford Health (SD). Kota has a passion for translational science, oversees the day-to-day operations of EPIC, and is actively involved in the scientific aspects of every project, from concept to execution.

    Nothing to disclose.

    Credit Designations Pending Approval.

    • Register
      • Applicant - $100
      • Auditor - Free!
      • Committee Member - Free!
      • Consultant - Free!
      • FACT Staff - Free!
      • Inspector - Free!
      • Inspector Trainee - Free!
      • Non-member - $100
      • Industry Representative - $200
      • Fellow - $50
    • More Information
  • LIVE EVENT!
    Includes Credits Includes a Live In-Person Event on 08-22-2024 at 10:00 AM (CDT)

    The 12th Quality Management Webinar Series theme is Embrace Change: Growing Your Cellular Therapy Services. Over two years, each webinar will focus on a separate step of implementing a new service and/or product into a program through the lens of experienced quality personnel. Purchase the entire live QM Series 12 Part 2 bundle here: https://learn.factglobal.org/p...

    Part 1 featured four webinars throughout 2023 and the beginning of 2024. You may find it helpful to review the concepts from Part 1 before diving into this continuation! You can purchase the QM Series 12 Part 1 On-Demand bundle here: https://learn.factglobal.org/p...

    At the conclusion of this live activity, participants will be able to:

    1. Identify assessment methods to evaluate a new service.

    2. Implement a new service evaluation process for policies, SOPs, outcomes, and training methods.

    3. Integrate evaluation practices to assess the effectiveness of the Quality Management Plan (QMP).

    Tracy Dodd, RN, MBA, CPHQ, FNAHQ

    FACT Consultant

    FACT

    HOST

    Tracy is responsible for assessing, analyzing, and recommending quality and clinical performance improvement processes. She collaborates with clinical service groups to provide division guidance to ensure the cancer service line is in compliance with regulatory and accreditation bodies. Dodd is a senior consultant for the Foundation for the Accreditation of Cellular Therapy (FACT) Consulting Services, a FACT Quality Inspection Auditor. Tracy previously served as the Quality Improvement Director for the Sarah Cannon Transplant and Cellular Therapy Network and, before that, as the Quality Improvement Committee Chair for the Medical College of Wisconsin BMT Program and as the Blood and Marrow Transplant Manager at Children’s Hospital of Wisconsin. Tracy has over 35 years of healthcare quality and accreditation/regulatory compliance experience, 25 years specific to adult and pediatric BMT Programs, and 25 years of transplant and cellular therapy management experience. She earned her diploma in nursing at Columbia Hospital School of Nursing and her MBA at the Keller Graduate School of Management.

    Nothing to disclose.

    Nicole Aqui, MD

    Director Stem cell Collection Service

    University of Pennsylvania Medical Center

    Dr. Nicole Aqui is an Associate Professor of Clinical Pathology and Laboratory Medicine at the University of Pennsylvania. She is also the attending Pathologist, Section Chief, and Apheresis Services for the division of Transfusion Medicine, Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania. Dr. Aqui is also the Director of the Clinical Service Center, Department of Pathology and Laboratory Medicine. Dr. Aqui is an Ambulatory EMR Operations Committee member, Residency Program Director, and Vice Chair of the Inclusion, Diversity, and Equity Committee. She completed her undergraduate degree in Cellular And Molecular Biology at the University Of Maryland College Park and her medical degree at the University of Pennsylvania School of Medicine.  She is an expert in transfusion medicine, apheresis, blood banking, hematopoietic stem cell and immune effector cell collection/processing, and sickle cell disease. Dr. Aqui has numerous publications and research.

    Nothing to disclose.

    Credit Designations Pending Approval.

    • Register
      • Applicant - $100
      • Auditor - Free!
      • Committee Member - Free!
      • Consultant - Free!
      • FACT Staff - Free!
      • Inspector - Free!
      • Inspector Trainee - Free!
      • Non-member - $100
      • Industry Representative - $200
      • Fellow - $50
    • More Information
  • REGISTER FOR THE LIVE BUNDLE!!

    This bundle series includes all the webinars from the 2024 QM Series 12 - Part 2 LIVE Webinars:

    1. How to Implement a New Process - August 1st 

    2. Evaluation of the Implementation of a New Process - August 22nd 

    3. Preparing for Interruption of Operations - September 18th 

    4. Program's Perspective: Three Views - November 6th


    To purchase the QM Series 12 - Part 1 On-Demand Bundle:  Purchase
    • Register
      • Early bird pricing available!
      • Applicant - $315
      • Auditor - Free!
      • Committee Member - Free!
      • Consultant - Free!
      • FACT Staff - Free!
      • Inspector - Free!
      • Inspector Trainee - Free!
      • Non-member - $315
      • Industry Representative - $540
      • Fellow - $155
      • Regular Price after 07-31-2024 7:07 PM
      • Applicant - $350
      • Auditor - Free!
      • Committee Member - Free!
      • Consultant - Free!
      • FACT Staff - Free!
      • Inspector - Free!
      • Inspector Trainee - Free!
      • Non-member - $350
      • Industry Representative - $600
      • Fellow - $175
    • More Information
  • LIVE EVENT!
    Includes Credits Includes a Live In-Person Event on 08-01-2024 at 10:00 AM (CDT)

    The 12th Quality Management Webinar Series theme is Embrace Change: Growing Your Cellular Therapy Services. Over two years, each webinar will focus on a separate step of implementing a new service and/or product into a program through the lens of experienced quality personnel. Purchase the live QM Series 12 Part 2 bundle here: https://learn.factglobal.org/p...

    Part 1 featured four webinars throughout 2023 and the beginning of 2024. You may find it helpful to review the concepts from Part 1 before diving into this continuation! You can purchase the QM Series 12 Part 1 On-Demand bundle here: https://learn.factglobal.org/p...

    At the conclusion of this live activity, participants will be able to:

    1. Discuss the importance of a new service's process flow map and training methods.

    2. Describe an effective communications and implementation plan for new processes.

    3. Establish a plan for performing qualifications and validations required, meeting labeling requirements, and managing data.

    Harminder Kaur-Singh, BSc, BA, SSGB, CPHQ

    Quality Assurance Advisor

    CHU Sainte-Justine - Cellular Therapy Program

    HOST

    Harminder Kaur-Singh is an accomplished professional with over 15 years of experience in regulatory compliance and quality improvement in the field of cell therapy. Harminder is a certified LEAN Green Belt and CPHQ, with extensive experience leading regulatory compliance and improvement efforts as both an employee and a consultant. As Quality Advisor for the Stem Cell transplant program at CHU Sainte-Justine in Montréal, Quebec, she works with all cell therapy sectors to ensure regulatory compliance and quality improvement efforts. Harminder serves as the Director-at-Large for Quality for the CTTC (Cell Therapy Transplant Canada) and co-chairs the Quality & Regulatory Committee for the CTTC.  Harminder is also a member of the ASTCT Quality Committee as well as being a member of the FACT Education Committee.

    No Disclosures.

    Susie Joron

    Hema-Quebec Donor & Cord Blood Registry Manager

    Héma-Québec

    Susie Joron serves as the Operations Manager at Hema-Quebec in Montreal, QC, where she has significantly contributed since 2013, particularly in developing stem cell donor and cord blood services. She holds a BSc in Microbiology and is pursuing an Executive MBA from Laval University in Quebec City, QC. Her areas of expertise include process development, strategic planning, quality & regulations, and operational efficiency.

    With over 15 years of experience in cellular therapy, Susie has also held key roles in stem cell transplant programs across Canada. Her responsibilities have encompassed the management of activities such as stem cell donor selection, recruitment, eligibility, and collection, as well as the importation of stem cell products. She has established international partnerships with the World Marrow Donor Association (WMDA) and its members. Recently, she became an inspector for the Foundation for the Accreditation of Cellular Therapy (FACT). Additionally, Susie is an active Swab The World Foundation board member.

    Credit Designations Pending Approval.

    • Register
      • Applicant - $100
      • Auditor - Free!
      • Committee Member - Free!
      • Consultant - Free!
      • FACT Staff - Free!
      • Inspector - Free!
      • Inspector Trainee - Free!
      • Non-member - $100
      • Industry Representative - $200
      • Fellow - $50
    • More Information
  • NEW! REGISTER NOW!!

    Discover the latest advancements, network with peers, and form new connections.
    Join FACT and ISCT-ANZ in Queenstown, NZ, this August for the

    ISCT ANZ 2024 Regional Meeting and pre-conference FACT Accreditation Workshop!

    Register for both meetings and receive a 50% discount! Use code ISCTANZ24 at checkout.

    Use the button below to register for the ISCT-ANZ Regional Meeting in Queenstown, NZ.

    REGISTER FOR ISCT-ANZ

    Return to this window and click the Finalize Your Registration process.

    Note: You must have your confirmation # from ISCT, or your credit card will be billed the remaining amount due.

    image


    Phyllis I. Warkentin, MD

    Chief Medical Officer

    FACT

    Topic: Overview of the FACT Accreditation Process

    Dr. Phyllis I. Warkentin is a founding member of FACT and has been serving as a board member and chief medical officer since the organization’s inception. In addition to her work with FACT, Dr. Warkentin has been the director of the unrelated bone marrow transplantation program at the University of Nebraska Medical Center since 1988 and a professor of pediatrics and pathology/microbiology at the University of Nebraska Medical Center since 1994. She attended medical school at the University of Minnesota, where she subsequently completed a residency in pediatrics and fellowships in pediatric hematology/oncology and blood banking.

    No Disclosures

    Joseph Schwartz, MD MPH

    Director of Transfusion Services

    H. Lee Moffit Cancer Center & Research Institute

    TOPIC: Overview of Fact Accreditation Process
    TOPIC: Leveraging FACT Accreditation to Reduce Audit Burdens

    Dr. Joseph Schwartz is the Director of Transfusion Medicine Services at the Moffitt Cancer Center in Tampa, FL. Dr. Schwartz is the Chair of the FACT Technology Committee and Co-Chair of the FACT Cellular Therapy Accreditation and Cord Blood Bank Accreditation Committees. In addition, he is a member of the FACT Standards Steering and Education committees. In the past, he served on the FACT Board of Directors. Dr. Schwartz has participated as an Apheresis and Marrow Collection, Cord Blood Banking, and Cord Blood Collection Inspector since 2006.

    No Disclosures.

    Guy Klamer, PhD

    Speaker Title

    Speaker Company

    TOPIC: Key to Compliance Application Success (w/Activity: Evaluating Compliance)

    Nothing to disclose

    Vicki Antonenas, BSc MSc (Med)

    Speaker Title

    Blood Transplant and Cell Therapies Laboratory, Westmead Hospital in Sydney Australia

    Topic: What to Expect During an Inspection

    Vicki is the Laboratory Director of the Blood Transplant and Cell Therapies Laboratory at Westmead Hospital, which is the largest laboratory in Sydney, preparing more than 380 products each year for infusions and performing over 1000 laboratory procedures for adult and pediatric patients undergoing transplantation and cell therapies to four Sydney BMT Hospitals. The laboratory also performs complex and specialized procedures involving extensive manipulation. The laboratory also receives and releases Immune Effector Cells, including CAR T cells. Vicki is also involved and responsible for all the administrative and scientific aspects of cellular cell processing and manipulation for HPCs and IEC, including compliance with national and international standards. She has been in this role for over 30 years at Westmead Hospital and has developed strong collaborations with national and international colleagues. Her interests have always been improving, teaching, and advancing all cell processing procedures for blood transplantation and cellular therapy. Her input and commitment to FACT and ISCT continue to grow. Vicki has been an active FACT inspector for cell processing laboratories for more than 12 years. 

    Nothing to Disclose

    Jessica Sue, BSc, MHSM

    Speaker Title

    Speaker Company

    Topic: Correction of Deficiencies

    Jessica Sue is the Quality Manager at the Sydney Cord Blood Bank, a FACT-accredited and TGA-licensed public cord blood bank. Jessica has gained industry knowledge in the regulatory requirements of cellular therapy organizations through her involvement in the FACT Quality Management Committee and ISCT ANZ Legal and Regulatory Affairs Committee, as a trainee FACT Inspector, and at various FACT Accreditation and Training Workshops. Jessica is also a founding co-chair of the ISCT ANZ Early Stage Professional (ESP) Subcommittee and holds a position with the global ESP Committee.   

    Nothing to disclose.

    Cheryl Hutchins, PhD

    Laboratory Director, BMT Laboratory

    Royal Brisbane & Women's Hospital

    Topic: Program Perspectives - Achieving Outcomes

    For 30 years, Cheryl has been the Laboratory Director of the Cellular Therapy Laboratory, Cancer Care Services at the Royal Brisbane & Women’s Hospital, the first haemopoietic progenitor cell transplant program accredited by FACT in Australia. The Cellular Therapy Laboratory is a large processing facility for the haemopoietic progenitor cell transplant and immune effector cell programs at the Royal Brisbane & Women’s Hospital and Queensland Children’s Hospital. As part of the HPCT program, the laboratory performs complex processing procedures such as CD34+ cell selection, TCRαβ depletion, or CD45RA depletion. As part of the CAR-T cell program, the laboratory has developed point-of-care production of CAR-T cells to provide treatment options for patients ineligible for government-funded commercial CAR-T cell therapies. 

    Nothing to disclose.

    Ngaire Elwood, PhD, BSc(Hons), MAICD

    Speaker Title

    Speaker Organization

    Topic: Maintaining FACT Readiness

    Nothing to disclose.

    • Register
      • Applicant - $250
      • Auditor - Free!
      • Committee Member - Free!
      • Consultant - Free!
      • FACT Staff - Free!
      • Inspector - Free!
      • Inspector Trainee - Free!
      • Non-member - $250
      • Industry Representative - $500
      • Fellow - $150
    • More Information
  • EARLY BIRD SPECIAL - REGISTER NOW!!
    Includes Credits

    This year's boot camp theme is Process Validations. FACT instructors will discuss how to develop a validation plan, including purpose, responsibilities, acceptance criteria, data collection, risk assessment, and summary of results. The day will begin with an overview of validations, verifications, and qualifications. Participants will be engaged in the development of validation plans for various processes. Participants should be prepared for a highly interactive virtual learning experience. Participants will hear expert presentations and engage in round table activities facilitated by experienced FACT Inspectors and quality personnel.

    Pricing

    Early Bird Registration* (Ends July 31st): $295

    *Industry representatives are not eligible for registration discounts and specialty pricing.

    Regular Registration: $345

    Industry Representative Registration: $1,000

    HOST: AA

    Host AA Title

    Host AA Organization

    Host & Topics: Welcome & Q&A Moderator

    Host Bio

    No disclosures.

    HOST: B

    Host Title

    Host Organization

    Topics: Welcome & What Have We Learned

    Host Bio

    No disclosures.

    Speaker A

    Speaker AA Title

    Speaker AA Organization

    Topic: FACT Matters: Improving Quality in Cord Blood Banking with FACT Accreditation

    No disclosures.

    Speaker B

    Speaker BB Title

    Speaker BB Organization

    Topic: What to Expect During the Inspection

    No disclosures.

    Speaker D

    Speaker DD Title

    Speaker DD Organization

    Topic: Panel Discussion: Three Approaches to Meeting Standards

    No disclosures.

    Speaker E

    Speaker EE Title

    Speaker EE Organization

    Topic: Panel Discussion: Three Approaches to Meeting Standards

    No disclosures.

    Speaker F

    Speaker FF Title

    Speaker FF Organization

    Topic: Correction of Deficiencies

    No disclosures.

    Facilitator A

    Facilitator A Title

    Facilitator A Organization

    Breakout #1: Roundtable 1 - Validation Plan, Acceptance Criteria & Outlining Steps of a Test Plan, Data Collection & Sample Size

    Breakout #3: Roundtable 2 - Execution of the Validation, Evaluation Data, Summary of Results, Review & Approval of Plan, Report, Conclusion

    No disclosures.

    Facilitator B

    Facilitator BTitle

    Facilitator B Organization

    Breakout #2: Roundtable 1 - Validation Plan, Acceptance Criteria & Outlining Steps of a Test Plan, Data Collection & Sample Size

    Breakout #4: Roundtable 2 - Execution of the Validation, Evaluation Data, Summary of Results, Review & Approval of Plan, Report, Conclusion

    No disclosures.

    Speaker GG

    Speaker GG Title

    Speaker G Organization

    Topic: Maintaining FACT Readiness w/Activity: Strategies to Maintain FACT Readiness

    No disclosures.

    Speaker H

    Speaker H Title

    Speaker H Organization

    Topic: Evaluation Data and Q&A

    No disclosures.

    Speaker I

    Speaker I Title

    Speaker I Organization

    Topic: Review & Approval of the Plan, Report, and Conclusion and Q&A

    No disclosures.

    image
    This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Illinois State Medical Society (ISMS) through the joint providership of Edward-Elmhurst Health and FACT. Edward-Elmhurst Health is accredited by ISMS to provide continuing medical education for physicians. This live activity is designated for a maximum of 8.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
    • Register
      • Early bird pricing available!
      • Applicant - $295
      • Auditor - Free!
      • Committee Member - Free!
      • Consultant - Free!
      • FACT Staff - Free!
      • Inspector - Free!
      • Inspector Trainee - Free!
      • Non-member - $295
      • Industry Representative - $1,000
      • Fellow - $175
      • Regular Price after 07-31-2024 10:37 AM
      • Applicant - $345
      • Auditor - Free!
      • Committee Member - Free!
      • Consultant - Free!
      • FACT Staff - Free!
      • Inspector - Free!
      • Inspector Trainee - Free!
      • Non-member - $345
      • Industry Representative - $1,000
      • Fellow - $175
    • More Information
  • The webinar highlights five perspectives on the ISBT 128 Split-Label. Each presenter delivers a 10-minute presentation and a collective round table discussion. The session ends with a dedicated period during which presenters respond to questions from the audience. 

    HOST

    Chief Medical Officer

    FACT

    Topic: Overview of the FACT Accreditation Process

    Dr. Phyllis I. Warkentin is a founding member of FACT and has been serving as a board member and chief medical officer since the organization’s inception. In addition to her work with FACT, Dr. Warkentin has been the director of the unrelated bone marrow transplantation program at the University of Nebraska Medical Center since 1988 and a professor of pediatrics and pathology/microbiology at the University of Nebraska Medical Center since 1994. She attended medical school at the University of Minnesota, where she subsequently completed a residency in pediatrics and fellowships in pediatric hematology/oncology and blood banking.

    No Disclosures

    Karen Moniz, MHA, MT(ASCB)SBB

    Technical Director

    ICCBBA

    Karen Moniz, MHA, MT(ASCP)SBB, is the Technical Director at ICCBBA. This international non-profit manages, develops, and licenses ISBT 128, the international information standard for terminology, coding, and labeling medical products of human origin (MPHO). She leads the ISBT 128 Standard's technical development to meet MPHO's global traceability needs. She studied medical technology at the University of Kentucky, immunohematology at Johns Hopkins Hospital, and healthcare administration at George Washington University. Karen spent decades managing blood donor centers, transfusion services, and biomedical information technology. An early advocate of the ISBT 128 Standard, she remains enthusiastic about the evolution of the ISBT 128 Standard to continue contributing to MPHO traceability, biovigilance, harmonization of terminology, and electronic data transfer.

    Nothing to disclose.

    Mary Grable McLeod, MLS(ASCP)cm SBBcm, SSGB (ASQ), CABP(H)

    Quality Manager – Blood and Marrow Transplant Cellular Therapy Facility

    Stanford Health Care

    Mary has over 25 years of experience in cellular therapy and transfusion service medicine. She earned her Bachelor of Science in Medical Technology from Rush University and her Bachelor of Arts in Liberal Arts from Monmouth College. Mary later completed the Specialist in Blood Banking program at Barnes Washington University. Mary started at Stanford Health Care in 1994 and has had various roles, starting as a Cell Therapy Technologist. Mary’s experience includes cellular therapy product collection, processing, cryopreservation, regulatory compliance, labeling, process improvement, audits, and quality management oversight. Mary is active with FACT, ISCT, and AABB organizations.

     

    Nothing to disclose.

    Nancy Hegdahl

    Quality Manager-Operations Support

    Be The Match BioTherapies

    Nancy Hegdahl is currently a Quality Manager at NMDP. Nancy and her team focus on Quality Systems that support Operational functions. She has held a range of roles in Quality Assurance and Quality Control throughout her career. She has held Quality management roles in regulated industries for the last ten years, overseeing quality systems governed by EPA or FDA regulations in GMP, GLP, and GTP. 

    Nothing to disclose.

    William Shingler, PhD MBA

    Senior Director, Patient and Cell Management

    Autolus Limited

    William leads Autolus’ Patient and Cell Management Team with a dual remit of Patient Scheduling and “Apheresis and Infusion Operations.” He has worked in cancer immunotherapy drug development for the past 20 years and, immediately before joining Autolus, led the technical onboarding of UK hospitals for Novartis’ Kymriah launch program.  Previously, he led the global clinical supply chain at Immunocore Limited (a T cell receptor-focused biotech) and held various clinical and drug development positions. Before this, William was the Principal Scientist in the clinical immunology group at Oxford BioMedica, focusing on their therapeutic cancer vaccine program.  In June 2018, William obtained an MBA with distinction from the University of Oxford, Säid Business School. He had previously gained his PhD studying apoptosis, cancer, and immunology at the University of Nottingham and the University of Edinburgh. He also holds a BSc in Biochemistry and Genetics from the University of Nottingham.

    Nothing to disclose.

    • Register
      • Applicant - $100
      • Auditor - Free!
      • Committee Member - Free!
      • Consultant - Free!
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      • Inspector - Free!
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      • Non-member - $100
      • Industry Representative - $200
      • Fellow - $50
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  • REGISTER FOR THE ON-DEMAND BUNDLE!!

    The 2023-2024 QM Series 12 theme is Embrace Change: Growing Your Cellular Therapy Services. Each webinar will equip your organization with practical strategies and insights to incorporate a new service or product into your cellular therapy organization while ensuring compliance, optimizing patient outcomes, and driving continuous improvement. Each webinar includes a 45-minute live lecture and a 15-minute Q&A session.

    This bundle series includes all the ON-DEMAND webinars from the 2023 QM Series 12 - Part 1:

    1. Facility Needs Assessment/Change Control
    2. Establishing Quality Indicators
    3. Written Agreements
    4. Program's Perspective: Three Views

    To purchase QM Series 12 - Part 2 LIVE Bundle: Purchase
    • Register
      • Applicant - $350
      • Auditor - Free!
      • Committee Member - Free!
      • Consultant - Free!
      • FACT Staff - Free!
      • Inspector - Free!
      • Inspector Trainee - Free!
      • Non-member - $350
      • Industry Representative - $600
      • Fellow - $175
    • More Information