Accreditation Statistics

As of January 2, 2024

Cellular Therapy Entities

  • Accredited: 260
  • Applicants: 26

Cord Blood Banks

  • Accredited: 49
  • Applicants: 10

Congratulations to the following organizations for achieving initial FACT accreditation:

  • Houston Methodist Ann Kimball & John W. Johnson Center for Cellular Therapeutics
  • Blood Assurance
  • American National Red Cross, Salt Lake City, Utah HCT/P Program

A complete list of accredited organizations can be found at www.factglobal.org.

Spotlight on Workforce Development Events Hosted by FACT Principal Members

Posted in :: 2024 Volume 1 :: Friday, January 26th, 2024

Workforce development is a critical need to fill the growing demand for cellular therapy, and the following are two events aimed to train up new professionals.

ASTCT Clinical Research Training Course Applications Open
July 10-13, 2024 in Park City, UT

Apply today to take part in the ASTCT Clinical Research Training Course (CRTC). This four-day program is specifically designed for fellow and junior faculty to advance research protocols. Scholars will have the opportunity to work one-on-one with expert faculty and statisticians through formal presentations, extensive follow-up dialogue and small-group discussion.

Twelve scholars will be selected for this exclusive training course, which has led to academic and career growth for past participants. Applications close March 15, 2024.

Learn more about the curriculum and eligibility requirements on the ASTCT website.

 

ISCT & CMaT Hands-On Laboratory Boot Camp for Cell Therapy Biomanufacturing
April 29-May 3, 2024 at Georgia Institute of Technology

This five-day, hands-on training covers techniques central to cell and gene therapy manufacturing, including aseptic cell culture, small- to large-scale cell manufacturing, product characterization, cell banking and documentation using GLP/GMP-like best practices.

Gain practical knowledge on:

  • The key steps to initiate, maintain, and expand cells in culture.
  • Downstream processes such as harvesting and cryopreservation.
  • How to perform sterility testing and cell product assessments.
  • How to apply GLP and GMP guidelines to document cell products.

Learn more about the course and how to register on the ISCT website. Registration is due March 29, 2024. Discounted rates are available for students and academia. Inquire at Raymond@ISCTGlobal.org.


FACT Launches 2024 Education Season

Posted in :: 2024 Volume 1 :: Friday, January 26th, 2024

We are thrilled to announce the launch of the 2024 FACT Education season! This year offers an array of enriching experiences both virtually and in-person across the globe.

Visit FACT’s Calendar of Events to register for upcoming education opportunities.

The 2024 FACT Quality Boot Camp spotlight shines on Process Validation, where FACT instructors delve into the intricacies of developing validation plans and will cover aspects such as purpose, responsibilities, acceptance criteria, data collection, risk assessment, and summary of results. The day kicks off with an enlightening overview of validations, verifications, and qualifications. Participants will actively engage in developing validation plans for critical processes, including Bone Marrow Collection, Preparation for Administration, and Infusion, ensuring a highly interactive learning environment.

Our interactive Cell Therapy Accreditation Workshop takes a deep dive into FACT’s Standards and accreditation process, offering a dynamic format facilitated by experienced instructors. Through case studies and collaborative discussions with peers, participants will gain insight into accreditation requirements, positioning their organizations for accreditation success, maintaining readiness, and addressing common citations. The workshop covers audits, corrective action plans, and strategies for enhancing clinical outcomes and data management.

For those aspiring to become FACT inspectors, training opportunities await. Tailored exclusively for inspector trainees who have completed prerequisites, the FACT Inspector Training Course offers practical, hands-on sessions led by experienced FACT inspectors, simulating the actual inspection process. Covering technology tools, preparation essentials, common citations, inspection procedures, and post-inspection expectations, this course provides a comprehensive foundation for those looking to contribute as FACT inspectors. To explore this exciting opportunity, contact Suzanne Birnley or visit https://www.factglobal.org/inspectors/.

Get ready for a season of unparalleled learning and professional growth with FACT Education in 2024!

Thank you to our partners for their generous support:

         

 

 


Register for Advanced Therapies Week 2023 in Miami – Discount Provided to FACT Readers

Posted in :: 2022 Volume 5 :: Friday, November 18th, 2022

The 2023 Advanced Therapies Week will again be on Miami Beach from January 17-20, 2023. This conference is intended to provide networking opportunities from morning until night and thought-provoking content and high-profile speakers. Registrants will include the breadth of the industry, and agenda tracks include:

  • Modalities and Indications.
  • Patient and Clinical Considerations.
  • Commercial.
  • Manufacturing.
  • Supply Chain and Tech Operations.
  • New and Enabling Tech.

Phacilitate has offered the FACT community a 15% discount on the registration fee. Take advantage of this cost savings to prepare for the next wave of advancements in cellular therapy. Use the discount code FACT15 when registering.

Learn more

Download the agenda

Register for the conference


FACT Clinical Inspector Training Course

Posted in :: 2022 Volume 5 :: Friday, November 18th, 2022

We invite you to attend the FACT Clinical Inspector Training Course in conjunction with the 2023 Tandem Meetings on Tuesday, February 14, from 8:00 am to 5:00 pm, at the World Center Marriott in Orlando, Florida. FACT’s Inspector Training Courses make learning about the inspection process an up-close and personal experience with practical, hands-on sessions simulating performing an inspection supplemented with presentations facilitated by experienced FACT inspectors.

The FACT Inspector Training Course is for clinical inspector trainees only. Trainees must complete all pre-training course requirements before attending. The training course is a collaborative event where the trainee will work with an experienced FACT inspector to review the entire inspection process from beginning to end.

FACT instructors will educate inspector trainees on the following topics during the inspector training course:

  • Inspection preparation essentials
  • Important technology tools
  • Advance review of documents
  • Clinical program tour
  • Facility documents
  • Patient record review
  • Post-inspection requirements

If you are interested in training as a FACT inspector, please contact the FACT office at fact@factglobal.org or visit https://www.factglobal.org/inspectors/.

Book your ticket NOW!


Don’t Miss Out on Early Bird Pricing for the FACT – ASTCT Quality Boot Camp!

Posted in :: 2022 Volume 5 :: Friday, November 18th, 2022

We invite you to attend the FACT – ASTCT Quality Boot Camp on Wednesday, February 15, from 8:00 am to 5:00 pm, at the World Center Marriott in Orlando, FL. This is a collaborative event where you will participate in a series of roundtable activities supplemented with presentations facilitated by experienced FACT inspectors and quality personnel.

The theme of the FACT – ASTCT Quality Boot Camp is: Strengthen your Quality Management Program through the Effective Use of Quality Tools. Using the right quality tool can help reduce errors, improve communication, help maintain compliance, and save programs time and resources while improving the overall quality of your program and processes.

During the quality boot camp, FACT instructors will discuss tools and techniques most commonly used in quality management and process improvement including:

  1. SWOT Analysis (Strengths, Weaknesses, Opportunities, and Threats)
  2. Risk Assessment and Failure Mode and Effects Analysis (FMEA)
  3. The Five Whys
  4. Fishbone/Ishikawa Diagram

Book your ticket NOW!


Future Stops in FACT’s 2022 Education Tour

Posted in :: 2022 Volume 5 :: Friday, November 18th, 2022

FACT Virtual Apheresis Collection and Processing Accreditation Workshop
Virtual, Wednesday, April 19, 2023
8:00 am – 5:00 pm CT

Book your ticket now! 

 

 


NOW OPEN!
FACT Apheresis Collection Inspector Training Course

Minneapolis, MN April 2023
8:00 am – 5:00 pm CT

Book your ticket now!

 

 



FACT Cord Blood Accreditation Workshop

Paris, France, May 30, 2023
8:00 am – 5:00 pm CT

Book your ticket now!

 

 



FACT Cord Blood Inspector Training Course

Paris, France, May 30, 2023
8:00 am – 5:00 pm CT

Book your ticket now! 

 

 



FACT Collection, Processing, and Cord Blood Virtual Quality Boot Camp

Virtual, June 23, 2023
8:00 am – 5:00 pm

 

Book your ticket now!

 

 



FACT Accreditation and Quality Principles Workshop

Perth, Australia, August 15, 2023
8:00 am – 5:00 pm

Registration Open Soon!

 

 



FACT Processing Inspector Training Course

Houston, TX, September 7, 2023
8:00 am – 5:00 pm

Book your ticket now!

 


FACT is Coming to a Location Near YOU!

Posted in :: 2022 Volume 4 :: Wednesday, October 26th, 2022

From Orlando to Paris, Minneapolis to Houston, FACT invites you to come with us on the 2023 Education Events Tour! Our 2023 education offerings include accreditation workshops, inspector training courses, and quality boot camps. These events are open to current and aspiring accreditation programs, FACT inspectors and trainees, quality personnel, and industry representatives. No matter your interests or where you are in your accreditation journey, we have an event that’s right for you!


The first stop is Orlando, Florida at the 2023 Tandem Meetings!


FACT Cellular Therapy Accreditation Workshop 

We invite you to attend the Cellular Therapy Accreditation Workshop in conjunction with the 2023 Tandem Meetings on Tuesday, February 14, from 8:00 am to 5:00 pm, at the World Center Marriott in Orlando, Florida. FACT’s accreditation workshops make learning about the accreditation process and related FACT Standards an up-close and personal experience. Accreditation workshops are collaborative events where you will be able to work through a series of scenario-based case studies supplemented with presentations facilitated by experienced FACT instructors.

The Cellular Therapy Accreditation Workshop provides a high-level overview of topics including requirements and expectations for accreditation, how to position your organization to pursue accreditation, and the most commonly cited standards. Additional areas of discussion include manufacturer audits and corrective action plans and audits to improve outcomes and data management.

Book your ticket NOW!

FACT Clinical Inspector Training Course 

We invite you to attend the FACT Clinical Inspector Training Course in conjunction with the 2023 Tandem Meetings on Tuesday, February 14, from 8:00 am to 5:00 pm, at the World Center Marriott in Orlando, Florida. FACT’s inspector training courses make learning about the inspection process an up-close and personal experience with practical, hands-on sessions simulating performing an inspection supplemented with presentations facilitated by experienced FACT inspectors.

The FACT Inspector Training Course is for clinical inspector trainees only. Trainees must complete all pre-training course requirements before attending. The training course is a collaborative event where the trainee will work with an experienced FACT inspector to review the entire inspection process from beginning to end.

FACT instructors will educate inspector trainees on the following topics during the inspector training course:

  • Inspection preparation essentials
  • Important technology tools
  • Advance review of documents
  • Clinical program tour
  • Facility documents
  • Patient record review
  • Post-inspection requirements

If you are interested in training as a FACT inspector, please contact Mikaela VanMoorleghem or visit https://www.factglobal.org/inspectors/.

Book your ticket NOW!

FACT – ASTCT Quality Boot Camp

We invite you to attend the FACT – ASTCT Quality Boot Camp on Wednesday February 15, from 8:00 am to 5:00 pm, at the World Center Marriott in Orlando, FL. This is a collaborative event where you will participate in a series of roundtable activities supplemented with presentations facilitated by experienced FACT inspectors and quality personnel.

The theme of the FACT – ASTCT Quality Boot Camp is: Strengthen your Quality Management Program through the Effective Use of Quality Tools. Using the right quality tool can help reduce errors, improve communication, help maintain compliance, and save programs time and resources while improving the overall quality of your program and processes.

During the quality boot camp, FACT instructors will discuss tools and techniques most commonly used in quality management and process improvement including:

  1. SWOT Analysis (Strengths, Weaknesses, Opportunities, and Threats)
  2. Risk Assessment and Failure Mode and Effects Analysis (FMEA)
  3. The Five Whys
  4. Fishbone/Ishikawa Diagram

Book your ticket NOW!


If you cannot join us in Orlando, future stops include:

FACT Virtual Apheresis Collection and Processing Accreditation Workshop
Virtual, Wednesday, April 19, 2023
8:00 am – 5:00 pm CT

Book your ticket now! 

 

 


FACT Apheresis Collection Inspector Training Course
Minneapolis, MN April 2023
8:00 am – 5:00 pm CT

Registration Open Soon!

 

 



FACT Cord Blood Accreditation Workshop

Paris, France, May 30, 2023
8:00 am – 5:00 pm CT

Book your ticket now!

 

 



FACT Cord Blood Inspector Training Course

Paris, France, May 30, 2023
8:00 am – 5:00 pm CT

Book your ticket now! 

 

 



FACT Collection, Processing, and Cord Blood Virtual Quality Boot Camp

Virtual, June 23, 2023
8:00 am – 5:00 pm

 

Book your ticket now!

 

 



FACT Accreditation and Quality Principles Workshop

Perth, Australia, August 7, 2023
8:00 am – 5:00 pm

Registration Open Soon!

 

 



FACT Processing Inspector Training Course

Houston, TX, September 7, 2023
8:00 am – 5:00 pm

Book your ticket now!

 


FACT Hosts Third Regenerative Medicine InterCHANGE

Posted in :: 2022 Volume 1 :: Monday, March 7th, 2022

Stakeholders are motivated – and ready – to implement practical, achievable changes to advance cellular therapy and regenerative medicine. This was a theme throughout the third Regenerative Medicine InterCHANGE, hosted by FACT virtually on January 25, 2022. The event was initially scheduled to be in Miami, Florida as part of Phacilitate’s Advanced Therapies Week, but changed to a virtual format due to the ripple effect of the increase in COVID-19 cases in the previous month.

A total of 36 attendees, representing 23 organizations and various areas of subject matter expertise, participated. Participating organizations included professional societies, health care providers, industry, information technology groups, advocacy organizations, accrediting organizations, and multistakeholder groups.

The three main objectives of the event were to:

  • Discuss regulatory requirements for the collection of starting material, applying approaches taken from currently licensed cellular therapies to anticipate and influence requirements for additional cell sources being investigated.
  • Develop a collaborative approach to educational and training programs, building and supporting a thriving workforce by leveraging the resources of academia and industry sectors.
  • Identify steps in the Investigational New Drug (IND) application, licensure, or equivalent regulatory process that could be addressed to reduce time and cost requirements in order to increase patient access to cellular therapies.

Each of these objectives were the topic of panel discussions. Panelists included a wide variety of stakeholders, whose perspectives brought fresh ideas to address challenges experienced among many different types of cellular therapy products. Audience participation was excellent, with attendees sharing ideas for many actionable solutions. A summary of the discussions and identified action items is currently being drafted.

Intermingled through the event were FACT Accreditation Success Story videos. Two videos highlighted successful multistakeholder efforts, including the ISBT 128 Standard 18 for labeling collected cells intended for further manufacture and streamlined site certification processes. The third and final video was a special message from a cellular therapy patient, shared by the Cord Blood Association, who encouraged cellular therapy professionals to continue their good work and be proud of their accomplishments.

The InterCHANGE planning committee and moderators, listed below, successfully narrowed seemingly daunting challenges into solution-driven discussions:

  • Ian McNiece, PhD: Chair, FACT Regenerative Medicine Task Force and Executive Consultant at CellMED
  • Joanne Kurtzberg, MD: Member, FACT Regenerative Medicine Task Force; President, Cord Blood Association; and Director of the Marcus Center for Cellular Cures and the Carolinas Cord Blood Bank, Duke
  • Corinne Goldberg, MD: Medical Director, Carolinas and South Carolina Region of the American Red Cross
  • David Moolten, MD: Medical Director, Penn-Jersey Region of the American Red Cross
  • Colleen Delaney, MD, MSc: Vice President, Cord Blood Association and Founder and Chief Scientific Officer of Deverra Therapeutics

We look forward to sharing the full summary with the cellular therapy field in the future. In the meantime, we would like to express a hearty thank you to the following organizations for participating in the event and for all your efforts to advance quality cellular therapy for the benefit of patients.


FACT Announces Events at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

Posted in :: 2019 Volume 9 :: Thursday, September 26th, 2019

We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!

FACT Cellular Therapy Inspection and Accreditation Workshop – February 18

FACT will conduct a Cellular Therapy Inspection & Accreditation workshop on February 18, 2019, at the World Center Marriott in Orlando, Florida. This workshop will provide an immersive experience for personnel preparing for the accreditation process and a full day training session for FACT inspector trainees.

Register for the FACT workshop
Apply to be a FACT inspector

Cellular Therapy Leadership Course 101 at TCT Meetings – February 18

Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you hone your leadership skills and acquire new ones that effectively encourage innovation, achieve consensus, build momentum, turn ideas into reality, eliminate distractions and guide a team toward goals.

Register for the Leadership Course 101

Cellular Therapy Advanced Leadership Course 201 at TCT Meetings – February 18

If you completed FACT’s Cellular Therapy Leadership 101 course and want more, the 201 course is for you.

This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cellular Therapy Leadership 101 course in the morning, or if attended in a previous year, are eligible to register for the 201 course in the afternoon.

Register for the Advanced Leadership Course 201

FACT-ASTCT Cellular Therapy Quality Boot Camp – February 19

Focused on issues identified by FACT compliant transplant programs, sessions will include activities and discussion designed to strengthen your quality assurance processes. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution.

Register for the FACT-ASTCT Quality Boot Camp

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session February 20

Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. This program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.

Register for the FACT Global Affairs session


FACT Events at the ISCT North American Regional Meeting a Success!

Posted in :: 2019 Volume 9 :: Thursday, September 26th, 2019

Cellular Therapy Inspection and Accreditation Workshop

FACT workshop presenter, Dr. Jean Sanders.

FACT was excited to be a part of the ISCT North American Regional Meeting in Madison, Wisconsin. Participants joined FACT on September 12, 2019, for the FACT Cellular Therapy Accreditation and Inspection workshop.   The workshop included individuals from the United States, Canada, and Australia.

Applicants discussed the challenges complying with FACT Standards and demonstrated how to overcome them; reviewed how to perform a risk assessment, practiced the use of the 5 Whys process, and evaluated the distribution of cellular therapy products. In addition, Dr. Jean Sanders presented about quality management in novel cell therapies.

Inspector Trainees participated in a separate training track in which they engaged in activities to effectively perform an inspection. Trainees worked with the inspection checklist and prepared comments noting noncompliance with standards, evaluated SOPs for training and competency, developed a plan for pre-inspection, and appraised unexpected issues that come up during an inspection along with proposed resolutions.

Sincere thanks to all of the participants, the invited speakers, the local organizers, and ISCT for their support.

ISCT-FACT Cellular Therapy Quality Boot Camp

Assessing Risk Assessment

Therese Dodd, Vice Chair of the FACT Quality Management Committee, welcomed the attendees and began the day with a presentation on “Assessing the Effectiveness of Your Quality Plan.”  A roundtable session followed where scenarios were used to evaluate the effectiveness of the QM Plan.  Federico Rodriguez discussed how the “Five Whys” can be used when evaluating occurrences, whether detected during an audit or when the occurrence is identified.  One of the most popular presentations was “Integrating Risk Assessment into Your Quality Program” presented by Amy Beres and Jennifer Frank. The FACT Quality Management Committee acknowledged Aurora Health Care Autologous Stem Cell Transplant Program’s risk assessment process as a commendable practice.  The attendees practiced using the risk assessment tools and over half indicated that they will incorporate this process at their program.

The afternoon began with “Supply Qualification” presented by Deborah Griffin and Emily Hopewell.  A supply qualification assessment tool was provided and used during a hands-on exercise.  A third of the attendees plan to update their supply qualification process with the information provided.  Ed Brindle provided an interesting history of Document Control as it relates to the FACT-JACIE Hematopoietic Cellular Therapy Standards and how the UHN Blood and Marrow Transplant (BMT) Program is transitioning to an electronic document control system.  The final presentation focused on planning audits and writing an audit report presented by Heather Conway, FACT-ISCT Data Audit Committee member.  During the audit activity session attendees used ISBT’s Audit Tool, and discussed how the tool can be used in conjunction with FACT labeling requirements in an internal audit.  The day ended with an opportunity to “Ask FACT” about issues, processes, and/or documents with a presenter of their choice.  Thank you to the attendees and presenters for great discussions throughout the day!

 

Boot camp attendees using the ISBT 128 Audit Tool

Boot camp attendees assessing risks related to occurrences

FACT Exhibit Booth

FACT welcomed visitors to its exhibit booth at the ISCT North American Regional Meeting.  We enjoyed visiting with new and familiar faces!

 


WMDA-NetCord & FACT Events at the Second Annual Cord Blood Connect International Congress Were a Success

Posted in :: 2019 Volume 9 :: Thursday, September 26th, 2019

The WMDA and FACT hosted a pre-conference Cord Blood Day at the 2019 Cord Blood Connect International Congress in Miami, Florida on September 12. Over 50 members of the cord blood community from eleven countries attended. The day included topics such as trends in cord blood banking, emerging pathogens, harmonization of testing procedures between cord blood banks and cellular therapy laboratories, and cord blood selection services for transplant centers. Breakout sessions in the afternoon included a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track.

In addition to the WMDA-NetCord & FACT Cord Blood Day, FACT welcomed visitors to its exhibit booth!

 

 

 

 

 

All events were successful and FACT looks forward to the next Cord Blood Connect International Congress September 10-12, 2020, in Miami Beach!

WMDA-NetCord & FACT presenters: Robyn Rodwell, Dunia Jawdat, and Heidi Elmoazzen

FACT Chief Medical Officer Phyllis I. Warkentin and WMDA-NetCord & FACT Cord Blood Day Chair Ngaire Elwood

WMDA-NetCord & FACT presenters: Alexander Platz, Gesine Koegler, and Phillip Johnson

 


FACT Announces ISCT-FACT Quality Boot Camp at the 2019 ISCT North America Meeting – September 12

Posted in :: 2019 Volume 7 :: Monday, July 29th, 2019

Is your lab FACT accredited or looking to comply with FACT standards? Strengthen your quality management programs through this interactive workshop with FACT experts and real world applications.

Focused on issues identified by FACT compliant programs, these sessions will include activities and discussion regarding Document Control, Risk Assessment in the Processing Laboratory, Supply Qualification, and Audit Plans and Writing the Report. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution. This boot camp is applicable not only to academic labs but also relevant for commercial operations.

We encourage programs to send multiple personnel to attend the various FACT events on September 12. The ISCT-FACT Quality Boot Camp is essential for all quality and laboratory personnel. The FACT Cellular Therapy Inspection and Accreditation Workshop taking place on the same day, is a must-see for cell processing laboratory personnel, physicians, scientists and principal investigators, administrators and nurses.

View details and register now
View preliminary agenda


FACT Events at ISCT Were a Success!

Posted in :: 2019 Volume 6 :: Thursday, June 13th, 2019

Chrissy Gordon: A Patient Perspective

FACT was honored to have its Cellular Therapy and Cord Blood Inspection and Accreditation Workshop in Melbourne, Australia opened by Ms. Chrissy Gordon, a recipient of an unrelated bone marrow transplant in 2000. Chrissy’s inspirational story of diagnosis, treatment, transplant, challenges, and successes over the past twenty years highlighted the importance of continuing to pursue improvements in the quality of patient care and advancing the promising developments in the field of cellular therapy.  Diagnosed with leukemia in 1999 at the age of 28, Chrissy was treated in Melbourne, but her matched donor was found half way around the globe in Omaha, Nebraska where the donation was made at the University of Nebraska Medical Center.  We first met Chrissy when she and her husband Dave visited Omaha to celebrate the 70th birthday of her marrow donor, Mr. Ken Vice of Lincoln, Nebraska.

Bone marrow transplant recipient Chrissy Gordon and her husband Dave shared her transplant story during the FACT Accreditation Workshop. 

ISCT-FACT Quality Boot Camp 2019

The 2019 ISCT Annual Meeting in Melbourne kicked off during the Pre-Conference Day with a packed house at the ISCT – FACT Quality Boot Camp on Wednesday, May 29, 2019.  Patrick Hanley, PhD presented timely information on incorporating immune effector cell activities into existing quality management programs. Guy Klamer, PhD discussed the importance of document control and common issues faced by cord blood banks.  Participants were actively engaged during an interactive session with Phillip Johnson on risk management, and were presented with several case scenarios and asked to assess the risk.  With validations being an important and challenging component of every cellular therapy facility, Robyn Rodwell, PhD and Annette Tricket, PhD provided details on the validation process and examples of their organizations’ results.  FACT’s Quality Manager, Heather Conway, addressed the important subject of auditing, focusing on the minimum requirements of an audit report and the “Five Whys.” The day concluded with a hands-on exercise using the ISBT 128 Audit Tool for Cellular Therapy.  The day was a great success and we look forward to future quality boot camps discussing core quality topics valuable to your organization. If you have ideas for future quality sessions, email  your ideas to FACT@UNMC.edu.

Quality Boot Camp participants work together on an activity applying quality principles to real-world scenarios.

 


The Countdown is on to Register for FACT Events at the ISCT Annual Meeting!

Posted in :: 2019 Volume 5 :: Friday, May 17th, 2019

Register Now and Save!

FACT Accreditation Workshop
Join your fellow cellular therapy and cord blood colleagues for several FACT events at the 2019 ISCT Annual Meeting in Melbourne, Australia.  On May 28th FACT will host a Cellular Therapy and Cord Blood Inspection and Accreditation Workshop from 8:00 am to 5:00 pm.  This workshop incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy and cord blood banking. Several hot topics include quality management in novel cell therapies, written agreements, and occurrence management.  Register before May 28th and save $100!

Fees are waived for active and trainee inspectors.  Apply to volunteer and train as a FACT inspector.

ISCT-FACT Quality Boot Camp
On May 29th ISCT and FACT will host a cellular therapy Quality Boot Camp for sessions that include activities and discussions addressing the following: IECs in Your Organizations Quality Plan and Written Agreements, Document Control, Performing Risk Assessment: Real Life Applications, Process Validation 101, and Evaluating and Reporting Audit Results. Register online for the ISCT Pre-Conference Day and attend the ISCT-FACT Cellular Therapy Quality Boot Camp! Note: ISCT Pre-Conference Day registration requires separate registration from the main ISCT Annual Meeting.

FACT Exhibit Booth
FACT representatives will be at exhibit booth #36 to provide information about FACT Standards and Accreditation. We would love to see new and familiar faces!

Exhibit Booth Dates and Times:

Wednesday, May 29th: 19:30 – 21:30
Thursday, May 30th: 09:00 – 19:30
Friday, May 31st: 09:00 – 18:30

Take advantage of these exciting FACT events by registering now! We look forward to seeing you in Melbourne!

 


FACT Events at the 2019 TCT Meetings Were a Success

Posted in :: 2019 Volume 3 :: Thursday, March 14th, 2019

FACT hosted several popular events at the 2019 TCT | Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR in Houston, Texas. Over 150 people joined FACT on February 19 for the Cellular Therapy Inspection and Accreditation Workshop, which included topics such as building quality into clinical immune effector cell programs, risk evaluation and mitigation strategies, using the Tracer Methodology to assess compliance with standards, common citations, reviewing clinical outcomes, and improving data management through follow-up. Also on February 19, FACT hosted two cellular therapy leadership courses for anyone who has, or aspires to, a leadership position in cell therapy.

On February 20, FACT teamed up with ASBMT to host the 4th annual Quality Boot Camp.  Over 130 people participated in the boot camp. This year’s agenda focused on topics such as dashboards and scorecards, record retention, risk assessment, integrating IECs into your HCT program, and evaluating the quality of your program through auditing. Quality experts presented core concepts, led roundtables, and answered questions to help others reach their quality management goals.

Special invitations were extended to all international delegates attending the TCT Meetings for a wine and cheese reception on February 21. The FACT Global Affairs: International Accreditation session provided attendees information about the international accreditation program featuring a stepwise certification approach. The new program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.

On February 21, in the session titled, Quality in HCT: Center-Specific Outcomes, Dr. Dennis Gastineau, FACT President and member of the FACT Clinical Outcomes Improvement Committee, shared guidelines for corrective action plans, and trends noted in the plans reviewed, including causes of death, challenges in root cause analysis, and ideas for improving one-year survival.

On February 22, FACT hosted a social hour for all FACT inspectors and inspector trainees in honor of their dedication and service provided to the cell therapy community. FACT relies on volunteer inspectors and appreciates their superior service, time, and expertise.

In addition to these events, FACT welcomed visitors to its exhibit booth to provide information about accreditation and educational activities.

All events were successful and FACT looks forward to the 2020 Transplantation and Cellular Therapy Meetings in Orlando, Florida!

FACT welcomed 150 attendees to the Cellular Therapy Inspection and Accreditation Workshop at the 2019 TCT Meetings.


FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session

Posted in :: 2019 Volume 1 :: Wednesday, January 16th, 2019

FACT International Accreditation

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 from 5:00 pm to 7:00 pm.

Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. The new program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements. Register to attend!


FACT-ASBMT Quality Boot Camp 2019

Posted in :: 2019 Volume 1 :: Wednesday, January 16th, 2019


The fourth annual FACT-ASBMT Quality Boot Camp, held in conjunction with the TCT | Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR, will be held on February 20, 2019.  Join the FACT Quality Management Committee and the ASBMT Administrative Directors SIG Quality group, and learn from your quality colleagues.  This year’s boot camp includes sessions on:

  • Developing a Dashboard: Program Status at a Glance
  • Performing a Risk Assessment in the Clinical Setting
  • Embracing Standardization to Create a Cohesive and Efficient System of Documentation
  • Vendor Qualification
  • Preparing for Immune Effector Cellular Therapy Accreditation
  • BMT After – Hours Call

A short self-assessment will be distributed in preparation for the boot camp to assess your needs and identify ongoing challenges.

View meeting details and register online
View the preliminary agenda