2024 FACT QM Series 12 - Part 2 LIVE Bundle

2024 FACT QM Series 12 - Part 2 LIVE Bundle

  • 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

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
  • 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.

  • 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.

  • 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.

  • 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.