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This module of the QM Series consists of sessions related to corrective action plans associated with cellular therapy programs and cord blood banks. Corrective Action Plans: Overview of Corrective Action Plans (February 16, 2022); QM Series 11, Corrective Action Plans: Developing a Corrective Action Plan (May 11, 2022); QM Series 11, Corrective Action Plans: Implement and Assess Effectiveness of Corrective Action Plan (August 24, 2022); QM Series 11, Corrective Action Plans, A Program's Perspective: (November 9, 2022)
Carlos Bachier, MD
Medical Director
Sarah Cannon Transplant and Cellular Therapy Program
Carlos R. Bachier, MD, is a board-certified Hematologist/Oncologist with the Sarah Cannon Transplant & Cellular Therapy Program at Methodist Hospital in San Antonio, Texas. He is also the Medical Director of Research and Cellular Therapy. While growing up, Dr. Bachier spent summers working at the clinic of his uncle, a pediatric endocrinologist. It was there he became interested in the field of medicine, as it combined his love of science with "detective work," or finding out what is wrong with someone.
After completing a Bachelor of Science in Chemistry from Tulane University in New Orleans, LA, Dr. Bachier received his medical degree at the University of Puerto Rico School of Medicine in San Juan, Puerto Rico. While in Puerto Rico, one of his mentors showed him how fascinating oncology treatment was. Dr. Bachier found oncology interesting because of the science of it, and it was the beginning of DNA abnormalities being discovered that would help determine future therapies.
After completing both his Residency in Internal Medicine and Fellowship in Hematology in San Juan, he came to the University of Texas Health Science Center in San Antonio for a Fellowship in Hematology and Medical Oncology. He worked at the MD Anderson Cancer Center after completing his fellowship. In the late 1990s, he returned to San Antonio and worked at the Texas Transplant Institute, where he eventually became program director. Dr. Bachier was then recruited to the Sarah Cannon Center for Blood Cancer as program director and as Director of Cellular Therapy Research at Sarah Cannon Research Institute. After six years as the Program Director at the Sarah Cannon Center for Blood Cancer in Nashville, Tennessee, he returned to Methodist Hospital in San Antonio.
He is a member of numerous professional associations, including the American Society of Hematology, the American Society of Clinical Oncology, and the American Society for Blood and Marrow Transplantation. He is also a member of the Sarah Cannon Blood Cancer Network, leading its Cellular Therapy Working Group.Bachier: Sanofi: Speakers Bureau; AlloVir: Honoraria; CRISPR: Honoraria; Juno Therapeutics, a Bristol-Myers Squibb Company: Honoraria.
Lisa Cantwell, MHA, CPHQ
Quality Manager
Stem Cell Transplant and Cellular Therapy Program of the Holden Comprehensive Cancer center at the University of Iowa
Lisa Cantwell is a certified Professional in Healthcare Quality (CPHQ). Twenty years of healthcare service management experience, including employee supervision, financial management, project management, budgeting, marketing, policy development, program development, quality assurance, and regulatory compliance. Lisa is the Senior Director of Authorized Treatment Center Operations at Iovance Biotherapeutics, Inc.
Cantwell: employee at Iovance Biotherapeutics, Inc.
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Register
- Applicant - $340
- Auditor - $340
- Committee Member - $340
- Consultant - Free!
- FACT Staff - Free!
- Inspector - Free!
- Inspector Trainee - Free!
- Non-member - $340
- Industry Representative - $700
- Fellow - $175
- More Information
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The 2023 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 will include a 45-minute live lecture and a 15-minute Q&A session. Ed Brindle, MSc, MLT is the Quality Manager for the Hamilton Health Sciences, Cellular Therapy and Transplantation Program.
After this webinar, attendees should be able to:
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Determine a timeline, regulatory requirements, and potential metrics to assess needs.
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Evaluate potential benefits and value added by performing a needs assessment.
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Identify gaps through change control and how they affect other processes within the program.
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Assess staffing, training, and product needs for the successful implementation of a new service.
Purchase the QM Series 12 - Part 1 On-Demand Bundle: PURCHASEEd Brindle
QA Manager - CTT Program
Hamilton Health Sciences
Ed's extensive educational background and professional certifications testify to his qualifications. He holds a Bachelor’s in Biological Sciences from Glasgow Caledonian University, a master’s in biomedical sciences at Napier University in Edinburgh, UK, and a Certificate in Quality Management with distinction at the University of Manitoba. Ed's unwavering dedication to quality management is evident in his over 30 years of experience as a Medical Lab Technologist in Hematology, Transfusion, Microbiology, Clinical Biochemistry, Quality Management, Cord Blood, and Cellular Therapy. He has served in various technical and managerial roles in the UK and Canada. He is the Quality Manager for the Cellular Therapy & Transplantation Service at The Juravinski Hospital and Cancer Centre, Hamilton Health Sciences, Ontario, Canada.
Ed has continued to represent Quality in the Clinical Laboratory and Cellular Therapy space and has presented at international scientific conferences and webinars related to Quality Operations, Cord Blood, and Cellular Therapy. He is a member of the FACT HPC Standards and Quality Management Committee, the Canadian Society for Medical Lab Science, and the Canadian Standards Association (CSA). He actively participates in the BMT and Cellular Therapy Laboratory National Standards. Ed continues to advocate for quality and loves to share his passion for continuous quality improvement to enable facilities to meet International Regulatory and Accreditation Standards.
No Disclosures.
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Register
- Applicant - $100
- Auditor - Free!
- Committee Member - $100
- Consultant - Free!
- FACT Staff - Free!
- Inspector - Free!
- Inspector Trainee - Free!
- Non-member - $100
- Industry Representative - $200
- Fellow - $50
- More Information
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The 2023 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 will include a 45-minute live lecture and a 15-minute Q&A session. Jacklyn Stentz, MBA, BSMT(ASCP), CPHQ, is the Director of Quality Improvement for the Sarah Cannon Transplant and Cellular Therapy Network.
After this enduring webinar, participants will be able to:
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Identify key stakeholders for developing indicators.
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Define endpoints and develop benchmarks.
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Recognize improvements while reflecting on expected outcomes.
Purchase the QM Series 12 - Part 1 On-Demand Bundle: PURCHASEJacklyn Stentz, MBA, BSMT(ASCP), CPHQ
Director Quality Improvement
Sarah Cannon Transplant and Cellular Therapy Network
Jackie has been in the transplant and cellular therapy field for twenty years. She joined the Sarah Cannon Transplant and Cellular Therapy Network in early 2022, where her primary responsibilities include ensuring compliance with accreditation and regulatory standards through standardizing policies, developing quality tool templates, establishing, and analyzing actionable quality metrics, facilitating mock inspections, and mentoring the quality managers at each of the Network programs. Jackie is a current member of the FACT Quality Management Committee and the FACT-JACIE International Standards for HCT Ninth Edition Quality Management Subcommittee.
No Disclosures.
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Register
- Applicant - $100
- Auditor - Free!
- Committee Member - $100
- Consultant - Free!
- FACT Staff - Free!
- Inspector - Free!
- Inspector Trainee - Free!
- Non-member - Free!
- Industry Representative - $200
- Fellow - $50
- More Information
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The 2023 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. Jay Tann, MS, RAC, is the quality assurance manager of the Children's National Health System Blood and Marrow Transplant Program.
After this enduring webinar, participants will be able to:
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Describe what a written agreement is and the purpose it serves.
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Identify when a written agreement is necessary based on FACT Standards.
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Compare and contrast quality agreements vs. financial/operational agreements.
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Determine what key elements should be included within written agreements.
Purchase the QM Series 12 - Part 1 On-Demand Bundle: PURCHASEJay Tanna
Quality Assurance Manager
Children's National Health System Blood and Marrow Transplant Program
Nothing to Disclose.
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Register
- Applicant - $100
- Auditor - Free!
- Committee Member - $100
- Consultant - Free!
- FACT Staff - Free!
- Inspector - Free!
- Inspector Trainee - Free!
- Non-member - $100
- Industry Representative - $200
- Fellow - $50
- More Information
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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:
- Facility Needs Assessment/Change Control
- Establishing Quality Indicators
- Written Agreements
- 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
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The 2023 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. This webinar includes 45 minutes of live lecture and a 15-minute Q&A session. Presentation #1 by Dr. Juan A. Merayo-Rodriguez, MD, CABP; Presentation #2 by Karen Collum, DNP, RN, OCN; Presentation #3 by Korrynn Vincent BS.
After this enduring webinar, participants will be able to:
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Presentation #1: Evaluate the requirements for new products or services; execute a change control workshop for new products or services; and demonstrate the management and documentation of change to comply with FACT Standards.
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Presentation #2: Construct actionable process metrics for clinical quality indicators; analyze outcome metrics for clinical quality indicators; and implement a benchmarking plan for clinical quality indicators.
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Presentation #3: Review the distinct types of written agreements describing appropriate review and approval processes; explain FACT's requirements for written agreements; and define quality agreements and outline their critical elements.
Purchase the QM Series 12 - Part 1 On-Demand Bundle: PurchaseJuan Merayo-Rodriguez, MD
Cord Blood Bank Director, LifeCord
LifeSouth Cord Blood Bank
No Disclosures.
Karen Collum, DNP, RN, OCN
Director, Nursing Quality
Memorial Sloan-Kettering Cancer Center - Blood and Marrow Transplant Program
No Disclosures.
Korrynn Vincent, BS
Laboratory Manager
Carolinas Cord Blood Bank at Duke
No Disclosures.
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Register
- Applicant - $100
- Auditor - Free!
- Committee Member - $100
- Consultant - Free!
- FACT Staff - Free!
- Inspector - Free!
- Inspector Trainee - Free!
- Non-member - $100
- Industry Representative - $200
- Fellow - $50
- More Information
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The Second Edition of the FACT Standards for Immune Effector Cells was published on December 15, 2023, and became effective on March 15, 2024. Nic Prokopishyn, PhD, Chair of the FACT Standards Development Committee, walks through and explains changes made from the first edition.
Nicole Prokopishyn, PHD
Cellular Therapy Lab Director
Alberta Blood and Marrow Transplant Program
Dr. Nicole Prokopishyn is currently serving as the Cellular Therapy Lab Director at the Alberta Blood and Marrow Transplant Program: Foothills Medical Centre, Alberta Children’s Hospital, Tom Baker Cancer Centre, and Calgary Laboratory Services. In this role, she oversees the provision of services for adult and pediatric transplants and cellular therapy. Nicole obtained her PhD in Biochemistry from the University of Saskatchewan. After completing her studies, she spent 10 years working abroad, with 5 years in Houston and 5 years in Philadelphia. During her time in these locations, she focused on the development of gene editing technologies in blood stem cells for the treatment of sickle cell disease and hemophilia. Nicole returned to Canada and accepted the director role at the Alberta Blood and Marrow Transplant Program, combining her expertise in quality assurance with a passion for treating patients through transplant and cellular therapy. Throughout her career, she has written numerous articles and presented her research findings internationally in the field of Cellular Therapy. Currently, she serves as the Chair of FACT's Standards Development Committee. In this role, she contributes to the development and enhancement of quality standards in this specialized field. Dr. Prokopishyn's extensive experience, dedication to improving patient outcomes, and commitment to advancing knowledge in the field make her one of the leading authorities in Cellular Therapy. Dr. Prokopishyn has been a FACT Inspector since 2013.
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Register
- Applicant - Free!
- Auditor - Free!
- Committee Member - Free!
- Consultant - Free!
- FACT Staff - Free!
- Inspector - Free!
- Inspector Trainee - Free!
- Non-member - Free!
- Fellow - Free!
- More Information
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Includes Credits
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.
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Register
- Applicant - $100
- Auditor - Free!
- Committee Member - $100
- Consultant - Free!
- FACT Staff - Free!
- Inspector - Free!
- Inspector Trainee - Free!
- Non-member - $100
- Industry Representative - $200
- Fellow - $50
- More Information
-
Register
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Includes Credits
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:
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Discuss the importance of a new service's process flow map and training methods.
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Describe an effective communications and implementation plan for new processes.
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Establish a plan to perform the required qualifications and validations, meet labeling requirements, and manage data.
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 the Illinois State Medical Society to provide continuing medical education to physicians. This enduring activity is designated for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
This activity is approved by NAHQ® for 1.0 hour of CPHQ CE credit.
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Register
- Applicant - $100
- Auditor - $100
- Committee Member - $100
- Consultant - Free!
- FACT Staff - Free!
- Inspector - Free!
- Inspector Trainee - Free!
- Non-member - $100
- Industry Representative - $200
- Fellow - $50
- More Information
-
-
Includes Credits
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:
-
Discuss the importance of a new service's process flow map and training methods.
-
Describe an effective communications and implementation plan for new processes.
-
Establish a plan to perform the required qualifications and validations, meet labeling requirements, and manage 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.
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Register
- Applicant - $100
- Auditor - $100
- Committee Member - $100
- Consultant - Free!
- FACT Staff - Free!
- Inspector - Free!
- Inspector Trainee - Free!
- Non-member - $100
- Industry Representative - $200
- Fellow - $50
- More Information
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