Join the 2023 FACT Education Tour!

Posted in :: 2022 Volume 6 :: Tuesday, December 20th, 2022

As the new year approaches, so does our upcoming tour of educational events! We are excited to see you in person or virtually. The following is a list of locations and sessions – which stop will you join?

Register for the 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 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 Suzanne Birnley at suzanne.birnley@factglobal.org or visit https://www.factglobal.org/inspectors/.

Book your ticket NOW!

Register for the 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

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 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!


ISCT and CMaT Announce Upcoming Course Dates for Successful Workforce Development in Biomanufacturing

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

The International Society for Cell & Gene Therapy (ISCT) and the NSF Engineering Research Center for Cell Manufacturing Technologies (CMaT) developed the Workforce Development in Biomanufacturing course to address workforce shortages in cellular therapies. Workforce shortages was a major topic of discussion at the 2022 FACT Regenerative Medicine InterCHANGE, and this program was highlighted as a potential solution.

Developed by academic, regulatory, clinical, and commercial experts, this program upskills key personnel for roles across the cell and gene therapy sector with modules including:

  • Module 1: Stem Cell and Immune Cell Engineering and Therapies
  • Module 2: Quality Assurance and Regulatory Framework
  • Module 3: Cell Bioprocessing and Manufacturing
  • Module 4: Cell Product Characterization and Importance of Standards

The inaugural course received positive reviews and attendees indicated that they would recommend the course to colleagues. Visit the ISCT website for detailed information on course dates, format, registration, and fee discounts.


Congratulations to Robert Preti for Receiving the Prestigious ISCT Career Achievement Award

Posted in :: 2022 Volume 2 :: Friday, June 17th, 2022

Robert A. Preti, PhD was awarded the 2022 ISCT Career Achievement Award at the ISCT Annual Meeting. This award is the highest honor awarded by the society and recognizes, “long and distinguished service to advancing the overall cell and gene therapy field, resulting in significant achievements that benefit patients.”

Dr. Preti played a key role in establishing FACT, and accreditation was just one of many areas he helped develop in cellular therapy. His contributions span scientific, academic, industry, and regulatory advancements.

Read more about Dr. Preti’s award and accomplishments


FACT Events Returned to In-Person Format in April and May 2022!

Posted in :: 2022 Volume 2 :: Friday, June 17th, 2022

FACT hosted several in-person education events this spring and one fundamental truth that became apparent following the COVID-19 pandemic is that we are social creatures who crave interaction! Despite the quick pivot we did to successfully do business virtually, we were anxious to get back to in-person meetings and conferences.

FACT and ASTCT hosted a Quality Boot Camp on April 22 at the 2022 Tandem Meetings.  Approximately 100 people participated in the boot camp. This year’s agenda focused on the program’s Quality Management Plan and the annual review of the effectiveness of the overall Quality Management Program.

FACT also welcomed visitors to its exhibit booth at the 2022 Tandem Meetings to provide information about accreditation and educational activities.

On May 3, FACT hosted a Cellular Therapy Collection Accreditation Workshop at the 2022 ASFA Annual Meeting. Topics included growing variations in collection requirements, labeling, and chain of identity and custody for IEC products collected in apheresis facilities, and creating a cohesive quality management program with an outside collection center.

Additionally, FACT hosted inspector training courses for clinical hematopoietic, immune effector cellular therapy, marrow collection, apheresis collection, and cell processing trainees at the meetings.  The courses guided trainees through the inspection experience including accepting an inspection assignment, submitting the inspection report, and participating in the relevant Accreditation Committee meeting.

All events were successful and FACT looks forward to future in-person education events!


ISCT Announces Educational Program on Advanced Therapy Manufacturing

Posted in :: 2021 Volume 5 :: Tuesday, October 26th, 2021

The International Society for Cellular Therapy (ISCT) announced the availability of the online Educational Program on Advanced Therapy Manufacturing, offered in partnership with the Andalusian Network for the Design & Translation of Advanced Therapies (And&tAT). The program is offered to ISCT members free of charge.

The program provides six self-serve online courses on the fundamentals of regulations on Advanced Therapy Medicinal Products (ATMPs), specifically for cell therapy, gene therapy, and tissue engineering. Course topics include:

  • Cell and Gene Therapy Manufacturing Methods.
  • Quality Assurance.
  • Product Development Pathways.
  • GMP Compliance.
  • Investigational Medicinal Product Dossier (IMPD) Writing.

Visit the ISCT website for specific course descriptions and instructions for enrolling.


ISCT Awards Honors to Dr. Catherine Bollard and Dr. Donald Kohn

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

The International Society for Cell & Gene Therapy (ISCT) announced the recipients of its 2021 achievement awards. Congratulations to Drs. Catherine Bollard and Donald Kohn!

Dr. Bollard, FACT’s President and long-time FACT inspector and committee volunteer, will be the first recipient of the Darwin J. Prockop Mentoring Award. This award recognizes, “an outstanding individual who has excelled as a mentor and has contributed to the ongoing development of their mentees in the field of cell and gene therapy.” The ISCT website quotes fellow FACT Board Member Patrick Hanley’s account of Dr. Bollard’s mentorship: “Cath’s impact on the field of cellular therapy and the practice of medicine is no longer restricted to her own success, but is now emanating in seeds she has planted and nurtured in the over 93 individuals she has mentored, including 22 junior faculty, 27 post doctoral fellows, and 12 graduate students. Dr. Bollard acts as a mentor to other senior investigators at CNH as well, particularly those in the Bone Marrow Transplantation division. Cath is the most deserving mentor for this award.

Dr. Kohn, a member of FACT’s Genetically-Modified HPC Subcommittee, will receive the 2021 ISCT Career Achievement Award. Dr. Kohn is a leader in research in gene therapy, and was instrumental in evaluating FACT Standards in the context of genetically modified cells and recommending additions to maintain the Standards’ relevance as these cells expand further into the clinic. Dr. Jan Nolta described to ISCT the most important contribution he has made, which has been to improve the lives of children: “Prof. Kohn developed the first successful hematopoietic stem cell gene therapy, for children with ‘bubble baby disease’- ADA deficiency – and has now functionally cured over 50 children.

Read more details

Register for the 2021 Virtual ISCT Annual Meeting


ISCT to Host Webinar on Apheresis Cellular Therapy Product Procurement for Further Manufacturing

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

On March 31, 2021, the International Society for Cellular Therapy (ISCT) will host a webinar titled, Apheresis Product Procurement. The webinar will include the experiences of a collection facility shifting from a service delivery mindset to one considering manufacturing in a regulated environment as manufacturing and clinical care documentation now begin with donor selection, qualification, and collection with more licensed products.

View more details and register


The Importance of Both Hope and Information when Battling Disease: A FACT Accreditation Coordinator’s Experience

Posted in :: 2020 Volume 7 :: Thursday, September 17th, 2020

By: Dina Becirovic, MPH, FACT Accreditation Coordinator

I lost a loved one to testicular cancer. At the time of his death two years after diagnosis, my cousin was more alive than most living people. He was an example of someone willing to try different treatments and travel far in the hopes of a cure.  He was in his early 40s and living in Bosnia when he was diagnosed early enough that the tumor could be removed. The follow-up scans showed the involvement of the lymph nodes, which were also removed. Subsequent scans showed elevated cancer markers, with additional scans showing nodules in the right lung and kidneys. He remained hopeful that he could still be cured. Holding onto hope, he turned to herbal supplements and cocktails. He would drink fluids that would “boost his immunity.”

With a poor prognosis, his last resort was coming to the United States. The cancer was inoperable at this point as it metastasized close to the walls of the aorta.  With the condition that far advanced, his treating physician indicated the stem cell transplant would yield a 10% chance of recovery and cancer remission. He passed away a week after receiving an autologous transplant, two years after his diagnosis. Even in his worst days, he was full of life, unscathed, hoping to see his son again. His experience showed the perseverance, hope, and desperation of someone who wanted to live.

A couple of months ago, I had the opportunity to attend a webinar on the topic of stem cell tourism (Gulera, 2020). This presentation reminded me of what I had already personally seen regarding the extent people are willing to go out of desperation, hope, and a desire to live.  My cousin’s experiments with outside remedies did not touch the surface compared to the extreme examples shown during the webinar. Stem cell tourism is often presented to patients as having the ability to treat or cure conditions and diseases such as diabetes, stroke, paralysis, or cerebral palsy (ISSCR, 2014). For example, because of a stem cell treatment in this setting, an individual lost an eye. Perhaps the most gruesome example of stem cell tourism was that of a man with an aggressive growing mass of someone else’s cells in the lower portion of his spine. For treatment and in hopes of finding a cure for quadriplegia post-stroke, that man paid $300,000 for injections (Kolata, 2016).

The International Society for Cell & Gene Therapy (ISCT) describes stem cell tourism as  “any unproven or insufficiently proven cell therapies proposed to patients as “treatments or therapies” for a specific financial cost and without recognized biological and medical proofs of safety and efficacy (i.e., without a positive benefit-risk assessment in place)” (ISTC, 2015, p.9).  These therapies are often offered to patients in clinics locally and worldwide. Most therapies are not part of the domain of conventional clinical trials, and no regulatory monitoring or information about risks or benefits is available. Furthermore, unproven cell therapies are characterized by the inability to confirm product quality and efficacy due to unclear scientific foundation or experimental procedures or consistency in cell manufacturing, inadequate consent forms, and failure to support clinical use due to incomplete research on action mechanism and biological function (ISCT, 2015).

The International Society for Stem Cell Research (2014) developed a Patient Handbook on Stem Cell Therapies, including stem cell tourism.  This resource provides a set of questions one might ask of the clinic or their provider. It also includes the warning signs a patient should look for should they ever find themselves in this situation.

FACT Standards require independent oversight by appropriate agencies, such as an Internal Review Board, ethics boards, and regulatory agencies; the disclosure of risks and benefits; and the disclosure of the cell source and how the cells will be collected, manufactured and administered. Additionally, FACT Standards reinforce training and continued annual competence of stem cell transplant physicians, advanced practice providers, and staff that are providing patient care in the stem cell transplant field. These requirements would mitigate the risks of stem cell tourism of clinics that voluntarily comply with them.

For a list of patient-related resources on Stem Cell Tourism and similar topics, visit the FACT website. Whatever you do for yourself or a loved one, be informed.

References

Gulera, I. (2020). Stem Cell Tourism [Webinar]. AABB Spanish Subsection.

Kolata, G. (2016, June 23). A Cautionary Tale of ‘Stem Cell Tourism’. https://www.nytimes.com/2016/06/23/health/a-cautionary-tale-of-stem-cell-tourism.html.

International Society for Cellular Therapy. (2015). ISCT Presidential Task Force on the Use of Unproven Cellular Therapies: Reference Guide. https://isctglobal.org/page/PTF2015 .

Mummery, C. L., Stolpe, A. van de, Roelen, B. A. J., & Clevers, H. (2014). Chapter 11. In Stem cells: scientific facts and fiction. Elsevier/AP, Academic Press is an imprint of Elsevier. https://doi.org/https://doi.org/10.1016/B978-0-12-411551-4.00011-8

 


FACT, ASTCT, CIBMTR, ISCT, and EBMT Publish Joint Statement Against Racism

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

Racism has no place in our society and profession. The American Society for Transplantation and Cellular Therapy (ASTCT), the Center for International Blood and Marrow Transplant Research (CIBMTR), Foundation for the Accreditation of Cellular Therapy (FACT), the International Society for Cell & Gene Therapy (ISCT), and the European Society for Blood and Marrow Transplantation (EBMT) all find these acts of racism reprehensible and inexcusable. This cannot be ignored any longer by the global community and our respective organizations.

We stand for the advancement of innovative, life-saving medicine. We know the importance of moving the needle forward in order to enact positive, powerful change. When it comes to issues of racism and violence, we realize the need for change, too.

We recognize that racism is an institutional problem in health care, and we are committed to doing our part to bridge that gap. We stand behind those who promote equality, diversity and inclusion. As a health care community, we have to do better—for not only the patients we serve, but the communities they live in as well.

As we work toward improving diversity and denouncing racism in health care and cities around the world, we commit to having the important conversations and supporting critical initiatives within our community that move us toward equality both in the transplantation, cellular and gene therapy workforce and in access to lifesaving therapies.

Please use this resource from the National Museum of African American History & Culture to educate yourself on the importance of talking about race and to find tools on combating racism in your own communities. We ask that you stand with us in denouncing racism and violence.


Canceled: FACT Cord Blood Inspection and Accreditation Workshop at ISCT Annual Meeting

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

The International Society of Cell and Gene Therapy (ISCT) has decided not to proceed with the ISCT 2020 in-person Annual Meeting, originally scheduled May 27 – 30, 2020 in Paris, France due to the coronavirus (COVID-19) pandemic. The ISCT 2020 Annual Meeting is rescheduled to take place virtually on May 28 and 29, 2020.  The virtual meeting will be accessible remotely and on-demand, including live and recorded sessions that are certified for CME and CMLE accreditation in addition to networking events, poster halls, and 1-on-1 partnering opportunities. The highly curated ISCT 2020 virtual meeting program will leverage state-of-the-art virtual meeting technology to provide the full ISCT Annual Meeting experience that you expect from ISCT.  For more details visit: http://www.isct2020.com/.

Because there will not be an in-person ISCT meeting, the associated FACT Cord Blood Inspection and Accreditation Workshop scheduled for May 26, and the ISCT-FACT Quality Boot Camp scheduled for May 27, 2020 have been cancelled.

If the FACT workshop is not rescheduled as a virtual session, your payment can be applied to the FACT workshop at the 2021 ISCT Meeting. If you prefer to receive a refund, please contact the FACT Business Manager, Jay Ann Witt at jawitt@unmc.edu.


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 is a Proud Partner of Advanced Therapies Week

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

Advanced Therapies Week, which will take place January 20-24, 2020 in Miami, Florida, will raise public awareness and support innovation in advanced therapies. Its organizer, Phacilitate, initiated this global campaign in conjunction with the Regenerative Medicine Foundation to support three areas:

  1. Public engagement
  2. Technology innovation
  3. Workforce development

The week will begin with a public day on January 20 at the renowned Frost Science Museum, during which interactive “activation” tables will allow members of the public to immerse themselves in concepts related to advanced therapies.

From January 21-24, the Phacilitate Leaders World and World Stem Cell Summit conferences will offer a comprehensive program with diverse tracks that address many aspects of advanced therapies – from raising capital and streamlining manufacturing processes to clinical delivery to patients. As a partner of Advanced Therapies Week, FACT participated in the development of the agenda and encourages the cellular therapy community to attend. Phacilitate has generously extended a 15% discount off the registration fee to the FACT community. To take advantage of this offer, enter the discount code FACT15 when prompted by the online registration process.

FACT will host the second Regenerative Medicine InterCHANGE on January 24, the last day of Advanced Therapies Week. During this meeting, attendees nominated by and representing organizations involved in cellular therapies will discuss solutions to the challenges identified with the development, testing, and commercialization of novel cellular therapies. In 2018, 17 organizations with complementary missions discussed specific challenges and created a list of action items based on their related initiatives. This year, over 30 organizations with broad perspectives of novel cellular therapies are invited to discuss progress on those action items and form working groups for challenges not yet addressed.

Advanced Therapies Week will also include programming for women in advanced therapies, stem cell and regenerative medicine action awards, advanced therapies 101 for the nursing professional, and a yacht party to celebrate advances in the field. The International Society Cell & Gene Therapy (ISCT), one of FACT’s parent organizations, will also be hosting a Commercialization Signature Series event.

Learn more about Advanced Therapies Week

Register for the Phacilitate Leaders World and World Stem Cell Summit conferences
Remember to enter FACT15 for a 15% discount.


Is Your Processing Facility an ISCT Lab Member?

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

Join ISCT as a Lab Member to meet your operational, training, and recruitment needs.

ISCT, as the global steward fostering the translation of cell and gene therapies to the clinic, providing educational resources and networking opportunities has partnered with FACT on this special offer:

  • Annual base fee of $500
  • Receive 3 complimentary technologist memberships with a 2020 ISCT Lab Membership

REFERRAL CODE [FACTLAB]*

FACT encourages your laboratory to take advantage of this opportunity and the following benefits:

  • Registered technologist access discounted member rates for ISCT-sponsored meetings and webinars – education and training aimed at providing solutions to quality, operational, and regulatory challenges in the CGT lab
  • Join the members-only ISCT LPC** Forum – Laboratory Lifeline: Principles and Practice to share ideas, best practices, experiences, mentor, and problem solve – NEW!
  • Stay on top of novel and innovative scientific and clinical studies with your annual subscription to Cytotherapy®, the official journal of ISCT
  • Learn about timely issues and advance in the field with your subscription to the Telegraft, the members-only bi-monthly e-newsletter
  • Recruit top talent through the ISCT Career Center to meet the growing demands in your lab.

There is no better time to be part of a global cell & gene therapy community focused on translation.

JOIN NOW!

Contact meagan@isctglobal.org to activate this special offer.

*Must be a FACT-accredited lab, new lab members only. Current ISCT Lab Members not eligible for this referral program. **Lab Practices Committee


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
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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


Agenda Announced for the FACT Cellular Therapy Inspection and Accreditation Workshop at the 2019 ISCT North America Meeting – September 12

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

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

View quality boot camp 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


Register Now for the ISCT North America 2019 Regional Meeting

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

Centered on the theme ‘Engineering the Future of Cell & Gene Therapies’’, the ISCT North America Regional Meeting showcases the latest emerging engineering strategies in regenerative medicine, ‘’off the shelf’’ cell therapy, advanced genome engineering tools and results from the clinic, including products with Fast Track and RMAT designations.

This program is complemented by technical workshops as well as a dedicated Quality & Operations Track addressing regulatory considerations for cell and gene therapies, stability programs, managing growth in the laboratory, CMC strategies for commercial approval, and the value of real world evidence.

Don’t miss this opportunity to connect with leading experts and peers in ‘’Mad City’’ Madison, Wisconsin.

Visit www.isct-na2019.com for the full speaker line-up and program schedule.

REGISTER TODAY!

Special Registration Offers

  • Groups of 5+ registrations receive 25% off
  • Student Rate of $50 USD for undergraduate, graduate, medical and pharmacy students. Rate includes 2020 ISCT E-Membership *
  • All registered delegates receive 25% off 2020 ISCT E-Membership*

*certain conditions apply, visit the registration page for details