Upcoming Events

Posted in :: 2021 Volume 1 :: Friday, January 29th, 2021

To provide the cellular therapy community with important educational content, FACT will continue hosting virtual events until it is safe to resume in person meetings. We are excited to announce two events in February 2021: a FACT Inspection and Accreditation Workshop and a FACT-ASTCT Quality Boot Camp.

FACT Inspection and Accreditation Workshop
February 4, 2021

This virtual workshop is on Thursday, February 4, from 7:30 am – 4:30 pm CT, 13:30-22:30 GMT. Applicants interested in accreditation are invited to this interactive workshop.  Information will interest initial applicants and those who have attended previously.

Additional workshop content will include common citations, data management, clinical outcome analysis, and an update on FACT virtual inspections.

Workshop Objectives:
• Describe the accreditation process.
• Evaluate documentation to ensure compliance.
• Organize the on-site inspection process.
• Plan a program tour.
• Identify strategies to support a successful inspection.
• Practice evaluating deficiencies.
• Prepare for a FACT Virtual Inspection.
• Identify significant changes to the eighth edition Cellular Therapy Standards.
• Summarize the expectations of inspectors and applicants for data management.
• Utilize tools to evaluate outcome data.

Attend an optional lunch session with two FACT-accredited programs who will share how FACT accreditation is beneficial while managing the COVID-19 pandemic.

Register for the virtual workshop

FACT-ASTCT Quality Boot Camp
February 5, 2021

Join us for the 2021 FACT-ASTCT Quality Boot Camp: Navigating a Changing Environment Using Quality Systems.

Discuss and explore core quality concepts throughout the day and learn how to apply those concepts to an example.  “Adding immune effector cells to program services” will be used to illustrate concepts learned and navigate components of the quality system from beginning to end, including:

  • Perform a Facility Needs Assessment
  • Develop a Change Control
  • Execute Risk Assessments
  • Determine what to Validate and Audit
  • Perform Validation(s)
  • Establish Quality Indicators
  • Perform Audits

At the end of the day, boot camp participants will be able to apply learned concepts to their own program needs when adding or changing components to their program.

Register for the virtual boot camp


FACT Announces Upcoming Virtual Events

Posted in :: 2020 Volume 9 :: Monday, December 14th, 2020

To provide the cellular therapy community with important educational content, FACT will continue hosting virtual events until it is safe to resume in person meetings. We are excited to announce two events in February 2021: a FACT Inspection and Accreditation Workshop and a FACT-ASTCT Quality Boot Camp.

FACT Inspection and Accreditation Workshop
February 4, 2021

This virtual workshop is on Thursday, February 4, from 7:30 am – 4:30 pm CT, 13:30-22:30 GMT. Applicants interested in accreditation are invited to this interactive workshop.  Information will interest initial applicants and those who have attended previously.

Additional workshop content will include common citations, data management, clinical outcome analysis, and an update on FACT virtual inspections.

Workshop Objectives:
• Describe the accreditation process.
• Evaluate documentation to ensure compliance.
• Organize the on-site inspection process.
• Plan a program tour.
• Identify strategies to support a successful inspection.
• Practice evaluating deficiencies.
• Prepare for a FACT Virtual Inspection.
• Identify significant changes to the eighth edition Cellular Therapy Standards.
• Summarize the expectations of inspectors and applicants for data management.
• Utilize tools to evaluate outcome data.

Attend an optional lunch session with two FACT-accredited programs who will share how FACT accreditation is beneficial while managing the COVID-19 pandemic.

Register for the virtual workshop

FACT-ASTCT Quality Boot Camp
February 5, 2021

Join us for the 2021 FACT-ASTCT Quality Boot Camp: Navigating a Changing Environment Using Quality Systems.

Discuss and explore core quality concepts throughout the day and learn how to apply those concepts to an example.  “Adding immune effector cells to program services” will be used to illustrate concepts learned and navigate components of the quality system from beginning to end, including:

  • Perform a Facility Needs Assessment
  • Develop a Change Control
  • Execute Risk Assessments
  • Determine what to Validate and Audit
  • Perform Validation(s)
  • Establish Quality Indicators
  • Perform Audits

At the end of the day, boot camp participants will be able to apply learned concepts to their own program needs when adding or changing components to their program.

Register for the virtual boot camp


View the FACT Virtual Workshop that Everyone is Talking About

Posted in :: 2020 Volume 9 :: Friday, December 11th, 2020

As reported in a previous newsletter article, the first FACT Inspection & Accreditation Virtual Workshop on September 21, 2020 was well received by those in attendance, and we are pleased to provide everyone with an opportunity to view the recording of the workshop.

The workshop began with an overview of the FACT accreditation process and continued with hands-on activities to guide the applicant through the accreditation process. Workshop objectives include:

  • Describe the accreditation process.
  • Evaluate documentation to ensure compliance.
  • Organize the on-site inspection process.
  • Plan a program tour.
  • Identify strategies to support a successful inspection.
  • Practice evaluating deficiencies.

A digital download of the workshop recording can be purchased from the FACT online store at competitive prices. As always, inspectors and inspector trainees may download the recording for free!

Purchase the virtual workshop recording


FACT Invites You to Join Us for a Webinar in Support of World Cord Blood Day

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

In anticipation of World Cord Blood Day, FACT invites you to attend a special Cord Blood webinar on Monday, November 16, 2020 at 10:00 am ET, 15:00 GMT. The purpose of this webinar is to discuss the current progress using UM171-expanded cord blood transplantation, as well as to understand the effect of the COVID-19 pandemic on cord blood collection and transplantation in France. This webinar is 90-minutes, complimentary, and will be presented in French. Slides will be available in both English and French.

Presenters include:

  • Maude Dumont-Lagacé, PhD, a clinical scientist at ExCellThera Inc. (Canada)
  • Catherine Faucher, Md, clinical hematologist and currently in charge of the strategic pole “collection and transplantation of HSC” at the Agence de Biomédecine. (France)

FACT also encourages you to join the Save the Cord Foundation on November 17 for a free live virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood.

Instructions for joining the FACT Webinar on November 16:

  1. Log into Webinar: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
  2. Meeting ID: 922 6984 5238
  3. Passcode: WCBD

_____________________________________________

French Translation

En préparation de la Journée Mondiale du Sang de Cordon, FACT vous invite à participer à un webinaire spécial le lundi 16 Novembre 2020 à 10.00 ET, 15:00 GMT. L’objectif de ce webinaire est de discuter les progrès récents liés à l’utilisation de la méthode d’expansion de cellules UM171 en transplantation de sang de cordon, et également de comprendre l’effet de la pandémie COVID-19 sur la collecte et la transplantation de sang de cordon en France. Ce webinaire de 90 minutes est gratuit et sera présenté en français. Les orateurs seront:

  • Maude Dumont-Lagacé, PhD, Spécialiste en Sciences Cliniques à ExCellThera Inc (Canada)
  • Catherine Faucher, MD, Hématologue Clinicienne, actuellement en charge du pôle “Prélèvement et greffes de CSH” à l’Agence de biomédecine (France)

FACT vous encourage également à rejoindre la Fondation Save the Cord le 17 Novembre pour une conférence virtuelle gratuite. Le programme comprendra des présentations d’introduction pour le public et des présentations académiques par des chercheurs et médecins transplanteurs renommés, sur les dernières avancées et les traitements utilisant le sang de cordon.

Instructions pour rejoindre le webinaire le 16 Novembre:

  1. Connexion au webinaire: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
  2. Identification de la conférence: 922 6984 5238
  3. Mot de passe: WCBD

Registration is Open for the FACT Inspection & Accreditation Virtual Workshop!

Posted in :: 2020 Volume 6 :: Monday, August 24th, 2020

September 15, 2020 – 8:00 am to 3:00 pm CDT/13:00 to 20:00 GMT

 

When one door closes, another one opens – and FACT’s first ever Inspection & Accreditation Virtual Workshop makes these words ring true! We wish all of our stakeholders good health and safety, and are pleased to offer a new workshop format to allow us all to come together again. After all, learning never ends.

The workshop co-chairs, Ngaire Elwood, PhD and Joseph Schwartz, MD, MPH, have been working hard with the FACT Education Committee and the international panel of presenters to offer an elegant and interactive learning experience. Registrants can choose either the cord blood or apheresis track, and will also have the opportunity to ask questions directly to leaders in accreditation, cord blood, or apheresis in the Lunch with Leaders session.

Following a combination of presentations, recordings, activities, games, and discussions; workshop attendees will leave the event being able to:

  • Describe the accreditation process.
  • Evaluate documentation to ensure compliance.
  • Organize the on-site inspection process.
  • Plan a program tour.
  • Identify strategies to support a successful inspection.
  • Practice evaluating deficiencies.

The year 2020 has made it even more obvious that a culture of quality is critical to providing quality patient care. With no travel required and low registration fees, several colleagues at your institutions can register for the event, thereby developing an even deeper understanding of FACT accreditation at your program.

“See” you at the workshop!

View workshop details

See workshop agenda

Register for the workshop


Upcoming Educational Events

Posted in :: 2020 Volume 6 :: Friday, August 21st, 2020

Register now:

Bringing a Stand-Alone Immune Effector Cell therapy Program into FACT Compliance

 

Upcoming Quality Management Series Module 10: Validation

Process Validation
Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP
October 14, 2020, 11:00 am ET, 15:00 GMT

Presenters will discuss the following:

  • Range to validate (where to start and when to stop), variables and extreme scenarios
  • Process validations (to include Bone Marrow process)
  • Verification: when is it needed

Register now

Software Validation

Presented by Robyn Rodwell, PhD and Guy Klamer, PhD
December 2, 2020, 4:00 pm ET, 21:00 GMT

Dr. Rodwell and Dr. Klamer will discuss the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include:

  • Critical electronic systems under the control of the organization (facility)
  • Spreadsheets
  • Vendor and organization responsibilities

Register now

Program Perspective on Validation

TBA

Register for the entire series to receive a 15% discount! 

Module 10 includes all of the upcoming webinars and the recording of the first webinar:

Validation Overview

Presented by Nicole Prokopishyn, PhD

August 19, 2020, 11:00 am ET, 15:00 GMT

Dr. Prokopishyn discussed the differences among Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.


SAVE THE DATE: FACT Announces Virtual Inspection & Accreditation Workshop

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020


FACT Education Events

Posted in :: 2020 Volume 1 :: Monday, January 27th, 2020

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

FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm

This training workshop is designed to explain the FACT accreditation requirements. FACT representatives will clarify the intent of the FACT-JACIE Standards and assist programs in organizing and preparing for the accreditation process. In addition, individuals interested in becoming a FACT inspector are encouraged to attend inspector training.

The workshop includes two tracks: Applicant training and inspector training. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.

The inspector training track is required for all inspector trainees. In order to attend this track, you must be pre-approved as an inspector trainee. This track is designed to guide the trainee through the inspection experience; from accepting an inspection assignment, through submitting the inspection report, and participating in the Accreditation Committee review. Each trainee will receive an inspection checklist accompanied by applicable inspection documents.

Interested in becoming a FACT Inspector? Apply to train as an inspector. If eligible, trainees attend free of charge!

Register for the FACT workshop

FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm

Join us for a day focused on core quality concepts. The sessions will include quality processes programs have implemented and incorporating Immune Effector Cells into all parts of your quality program. A self-assessment will be distributed prior to the TCT Meeting to review key features of your quality program and identify ongoing challenges. Complete the self-assessment, join the roundtable discussions, participate in the activities, and leverage QA experts for ideas on how to take your program’s quality program to the next level.

Register for the FACT-ASTCT Quality Boot Camp

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 20, 2020
5:00 pm – 7:00 pm

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASTCT & CIBMTR to be held in Orlando, FL at the Orlando World Center Marriott on Thursday, February 20, 2020, 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 in Latin America, the new joint FACT-SBTMO Accreditation Program in Brazil, and efforts to provide guidance to transplant centers in India. 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 Cord Blood Inspection & Accreditation Workshop
May 26, 2020
8:00 am – 5:00 pm

This training workshop is designed to explain the FACT accreditation requirements. FACT representatives will clarify the intent of the NetCord-FACT Standards and assist programs in organizing and preparing for the accreditation process. In addition, individuals interested in becoming a FACT inspector are encouraged to attend inspector training.

The workshop includes two tracks: Applicant training and inspector training. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.

The inspector training track is required for all inspector trainees. In order to attend this track, you must be pre-approved as an inspector trainee. This track is designed to guide the trainee through the inspection experience; from accepting an inspection assignment, through submitting the inspection report, and participating in the Accreditation Committee review. Each trainee will receive an inspection checklist accompanied by applicable inspection documents.

Interested in becoming a FACT Inspector? Apply to train as an inspector. If eligible, trainees attend free of charge!

Register for the FACT workshop

FACT Cord Blood Inspection & Accreditation Workshop
September 9, 2020
8:00 am – 5:00 pm

This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will clarify the intent of the NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.

The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.

Apply to train as a FACT inspector. If approved, you can attend the workshop FREE of charge!

This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. We encourage banks to send multiple personnel to be able to attend both the applicant and inspector training track!


FACT Announces Cord Blood Inspection and Accreditation Workshop at the 2020 ISCT Annual Meeting, Paris

Posted in :: 2019 Volume 10 :: Thursday, October 31st, 2019

FACT Cord Blood Inspection and Accreditation Workshop
Tuesday, May 26
8:00 am – 5:00 pm

This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will clarify the intent of the NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.

The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. Inspector trainees have required assignments to complete before attending the workshop. In order to attend this track, you must be pre-approved as an inspector trainee.

Apply to train as a FACT inspector.  If approved, you can attend the workshop FREE of charge! Eligible Cord Blood Bank personnel are encouraged to serve as a volunteer FACT inspector and enjoy the following value-added benefits:

Exposure to Exemplary Practices

As an inspector, you can observe how other facilities meet FACT Standards and bring home new ideas. Interaction with inspection team members also provides the opportunity to network and collaborate.

Professional Development

Improve your knowledge of FACT requirements and serve as an asset in ensuring your organization meets Standards. “FACT Inspector” also looks great on a curriculum vitae.

Influence

Inspectors have influence over FACT policies and requirements. Input from FACT inspectors is sought in the process of developing new editions of Standards.

Free Access to FACT Educational Resources

As a volunteer, you will have free access to both in-person and online educational events with an annual value over$1,800.

Information about qualifications and how to apply to become a FACT inspector can be found on the FACT website. If you have any questions, please contact Mikaela VanMoorleghem or the FACT office.

Are you ready?


FACT Education Events

Posted in :: 2019 Volume 10 :: Thursday, October 31st, 2019

FACT – Héma-Québec – Liège Cord Blood Bank Cord Blood Webinar in Support of World Cord Blood Day
November 14, 2019
10:00 am ET, 15:00 GMT, 16:00 CET

In anticipation of World Cord Blood Day, FACT, along with Héma-Québec and Liège Cord Blood Bank, invites you to attend a special Cord Blood webinar on Thursday, November 14, 2019 at 10:00 am ET, 15:00 GMT, and 16:00 CET. The purpose of this webinar is to better understand immunogenetic diversity in registries and cord blood banks, as well as cord blood transplantation and emerging pathogens. This webinar is free of charge and will be presented in French. Slides will be available in both English and French. Topics include:

• Immunogenetic Diversity in Registries and Cord Blood Banks: Dr. Eliane Gluckman
• Cord Blood Transplantation and Emerging Pathogens: Is there reason for concern? Dr. Gilles Delage
• Personal experience from a cord blood recipient

FACT also encourages you to join the Save the Cord Foundation on November 15 for a free live virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood.

Instructions for joining the FACT Webinar on November 14:
1. Log into webinar:
https://factwebsite.webex.com/factwebsite/onstage/g.php?MTID=eda55e6eaf311dc8ea9de4e66281dde89
2. Enter your name and email. Click “Join Now.”
3. If requested, enter the event number: 666 195 982
4. Adjust computer audio to desired volume.
_____________________________________________

French Translation

En préparation de la Journée Mondiale du Sang de Cordon Ombilical, nous vous invitons à participer à un séminaire en ligne spécial qui aura lieu jeudi le 14 Novembre 2019 à 10:00 HNE, 15:00 GMT, and 16:00 CET. L’objectif de ce séminaire est de mieux comprendre la diversité immunogénétique dans les registres et les banques de sang de cordon, ainsi que les agents pathogènes émergents dans le cadre de transplantation. Ce séminaire est gratuit et sera présenté en Français. Les diapositives seront disponibles en français et en anglais.
Liste des sujets:

• Diversité immunogénétique dans les registres et banques de sang de cordon: Dr. Eliane Gluckman
• Transplantation de sang de cordon et pathogènes émergents: est-ce un sujet d’inquiétude? Dr. Gilles Delage
• Expérience personnelle du receveur d’une greffe de sang de cordon.

FACT vous encourage également à vous joindre à la Fondation Save the Cord le 15 Novembre pour une conférence virtuelle gratuite. Le programme comprendra des présentations pour le grand public ainsi que des présentations académiques par des chercheurs et des médecins transplanteurs réputés sur les récentes avancées et thérapies utilisant le sang de cordon ombilical.

1. Se connecter au séminaire:
https://factwebsite.webex.com/factwebsite/onstage/g.php?MTID=eda55e6eaf311dc8ea9de4e66281dde89
2. Saisir votre nom et adresse email. Cliquer “Join Now.”
3. si demandé, entrer le numéro de l’événement: 666 195 982
4. Ajuster le volume de votre ordinateur au niveau désiré.

FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm

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

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will clarify the intent of the FACT-JACIE Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.

The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.

Register for the FACT workshop

FACT Cellular Therapy Leadership Course 101 at TCT Meetings
February 18, 2020
8:00 am – 12:00 pm

Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you recognize 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 FACT Leadership 101 course

FACT Cellular Therapy Advanced Leadership Course 201 at TCT Meetings
February 18, 2020
1:00 pm – 4:30 pm

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 FACT Advanced Leadership 201 course

FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm

Join us for the FACT-ASBMT Quality Boot Camp at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 19 in Orlando, FL.

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, 2020
5:00 pm – 7:00 pm

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Orlando, FL at the Orlando World Center Marriott on Thursday, February 20, 2020, 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. 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 Cord Blood Inspection & Accreditation Workshop
May 26, 2020
8:00 am – 5:00 pm

This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will clarify the intent of the NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.

The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.

Apply to train as a FACT inspector.  If approved, you can attend the workshop FREE of charge!

Register for the FACT workshop


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 Education Events

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

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 2
October 9, 2019
Webinar

The second webinar in this two-part series will be on Wednesday, October 9, 2019 at 11:00 am ET. Part two includes information from Dr. Joseph Alvarnas from City of Hope. Dr. Alvarnas will give his perspective as a hospital administrator in regard to the following:

  • Agreements with Manufacturers
  • Reimbursement

View meeting details and register

Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar

This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, FACT Standards Development Chair, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.

View meeting details and register

FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm

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

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

FACT Cellular Therapy Leadership Course 101 at TCT Meetings
February 18, 2020
8:00 am – 12:00 pm

Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you recognize 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 FACT Leadership 101 course

FACT Cellular Therapy Advanced Leadership Course 201 at TCT Meetings
February 18, 2020
1:00 pm – 4:30 pm

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 FACT Advanced Leadership 201 course

FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm

Join us for the FACT-ASBMT Quality Boot Camp at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 19 in Orlando, FL.

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, 2020
5:00 pm – 7:00 pm

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Orlando, FL at the Orlando World Center Marriott on Thursday, February 20, 2020, 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. 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 Education Events

Posted in :: 2019 Volume 8 :: Thursday, August 29th, 2019

WMDA-NetCord & FACT Cord Blood Day
September 12, 2019
Miami Florida

The World Marrow Donor Association (WMDA) and Foundation for the Accreditation of Cellular Therapy (FACT) are teaming up to host the second annual pre-conference WMDA-Netcord & FACT Cord Blood Day. The workshop incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp, and FACT Inspector Training.

We encourage banks to send multiple personnel to attend the various tracks and enlist a member to become a FACT inspector.  Registration fees are waived for FACT inspectors and trainees. Apply to become a FACT inspector!

Join leading cord blood experts from around the world for a day of education and hands-on breakout sessions.  We look forward to seeing you in Miami!

View meeting details and register
View meeting agenda

 

 

 

 

 

 

 

 

 

 

 

 

FACT Events at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI

FACT is hosting two events on pre-conference day at the ISCT North American 2019 Regional Meeting. On September 12, colleagues have the opportunity to attend the FACT Cellular Therapy Inspection and Accreditation Workshop, or the ISCT – FACT Quality Boot Camp.

We encourage programs to send multiple personnel to attend the various FACT events on September 12.  The FACT Cellular Therapy Inspection and Accreditation Workshop is a must-see for cell processing laboratories, physicians, scientists, and principal investigators, and unit supervisors, laboratory managers, administrators, nurses, and medical technologists.  The ISCT-FACT Quality Boot camp, which takes place on the same day as the workshop, is essential for program quality managers.

View workshop meeting details and register
View workshop agenda

View boot camp details and register now
View boot camp agenda

 

 

 

 

 

 

 

 

 

 

 

 

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 2
September 25, 2019
Webinar

The second webinar in this two-part webinar series will be on Thursday, September 25, 2019 at 11:00 am ET. Part two includes information from Dr. Joseph Alvarnas from City of Hope. Dr. Alvarnas will give his perspective as a hospital administrator in regard to the following:

  • Agreements with Manufacturers
  • Reimbursement

View meeting details and register

Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar

This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.

View meeting details and register


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


Education Events

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

FACT-SBTMO Cell Therapy Accreditation Workshop
July 31, 2019
Brasília, Brazil

This training workshop is designed to explain the requirements of the FACT-SBTMO joint cell therapy accreditation program in Brazil. FACT and SBTMO representatives will be in attendance to:
• Provide an overview of the FACT Standards and accreditation process
• Explain how to integrate quality management into clinical, collection, and cell processing programs
• Examine how to prepare for a successful inspection
• Summarize how controlling documentation can improve your program
• Review commonly cited Standards
• Outline the inspector orientation process
• Answer questions

This workshop is from 8:00 to 13:15 on Wednesday, July 31, 2019.

View meeting details and register 

WMDA-NetCord & FACT Cord Blood Day at 2019 Cord Blood Connect International Congress
September 12, 2019
Miami, FL

The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp track, and a FACT Inspector Training Track. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.

Topics will include:

  • Global perspectives of the regulation of cord blood banking,
  • WMDA serious adverse events and reactions,
  • Analysis of CD34+ and CD45+ cells in thawed cord blood samples,
  • Analysis of cellular viability in thawed cord blood,
  • Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards, and
  • Essential Quality Management Principles

The afternoon offers two tracks:

  • WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.
  • FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.

This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. We encourage banks to send multiple personnel to be able to attend both the Quality Boot Camp and nominate a member of your team to train to become a FACT inspector! Register before August 31st to receive the special advanced rate!

View meeting agenda

FACT Cellular Therapy Inspection and Accreditation Workshop at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI

This workshop in Madison incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy. Several hot topics include quality management in novel cell therapies, environmental monitoring, and occurrence management. These sessions are designed to help applicants navigate the evolving changes in the field. The agenda also includes training for new inspectors with real-world examples and exercises to guide them through the inspection process. This is a must-see event for the following audiences:

• Blood and marrow transplant (BMT) programs
• Cell processing laboratories
• Physicians, scientists, and principal investigators
• Unit supervisors, laboratory managers, administrators, nurses, and medical technologists

The day includes an applicant track and inspector training track. Inspector trainees are required to attend the inspector orientation track.

We encourage programs to send multiple personnel to attend the various FACT events on September 12.  The FACT Cellular Therapy Inspection and Accreditation Workshop is a must-see for cell processing laboratories, physicians, scientists, and principal investigators, and unit supervisors, laboratory managers, administrators, nurses, and medical technologists.  The ISCT-FACT Quality Boot Camp, which takes place on the same day as the workshop, is essential for program quality managers.

View meeting details and register
View meeting agenda

ISCT-FACT Quality Boot Camp at the 2019 ISCT North America Meeting
September 12, 2019
Madison, WI

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

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 2
September 25, 2019
Webinar

The second webinar in this two-part webinar series will be on Thursday, September 25, 2019 at 11:00 am ET. Part two includes information from Dr. Joseph Alvarnas from City of Hope. Dr. Alvarnas will give his perspective as a hospital administrator in regard to the following:

• Agreements with Manufacturers
• Reimbursement

View meeting details and register 

Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar

This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.

View meeting details and register