Introducing FACT Audit & Assessment Services: Streamlining Site Assessments for Enhanced Patient Access

Posted in :: 2024 Volume 2 :: Tuesday, April 9th, 2024

By Shawn Phillips, FAAS Auditor

We are excited to announce the official launch of FACT Audit & Assessment Services (FAAS), a new solution provided by FACT Consulting Services aimed at improving site assessments in the cellular therapy industry. Our mission is simple: to optimize patient care and enhance access to cellular therapies by streamlining the auditing process for all stakeholders involved.

In response to the growing demand for efficient assessment solutions in the rapidly evolving landscape of cell and gene therapy products, FAAS offers a new approach. Our services are designed to rapidly evaluate sites’ capabilities, facilitating their integration into companies’ networks while significantly reducing the burden of duplicative audits on healthcare sites.

FAAS is positioned to provide a singular, comprehensive assessment of collection and/or treatment sites via an assessment process that will become familiar to sites, providing a single audit summary report that can be leveraged by multiple companies.

Why FAAS Matters

With the development of numerous cell and gene therapy products, the need for qualified sites has never been more urgent. FAAS addresses this need by offering:

  • Efficiency: Our streamlined assessment process saves time and resources for both healthcare sites and industry players, allowing them to focus on delivering cutting-edge treatments to patients.
  • Quality Assurance: FAAS verifies that sites meet quality standards and regulations, providing assurance to companies and patients alike.
  • Enhanced Patient Access: By reducing the audit strain on industry sites, FAAS enables them to serve a broader patient population, ultimately advancing the goal of improving patient outcomes.

Why FAAS Can be the Ultimate Solution

  • Proven Process: Our methodologies are based on the globally trusted FACT accreditation program for cellular therapy, providing comprehensive evaluation and guidance for corrective actions.
  • Optimizing Access: We utilize consistent audit and assessment procedures and leverage existing reports to reduce the burden of repetitive audits, accelerate site qualification, and enhance access to cellular therapy for patients.
  • Tailored Programs: We design audit and assessment programs tailored to clients’ specific needs, whether it’s scope, geography, frequency, or number of sites.
  • Balanced Approach: We strike a balance between standardization and customization, optimizing quality at non-accredited sites and leveraging existing FACT accreditation to streamline audits.
  • Addressing Challenges: Say goodbye to unclear requirements and resource allocation issues. Our services alleviate the time, workforce, and financial burden of site certification on both health care sites and industry.

Meet Our Team

Leading FAAS is Liz Ferraro, Manager of Audit and Assessment Services. She is a seasoned Quality Manager with over 30 years of experience in healthcare quality management. With a proven track record at Nebraska Medicine Apheresis Program and LifeNet Health, Liz brings a wealth of expertise to her role.

 

 

 

 

Shawn Phillips, FAAS Auditor, is a quality auditor with a clinical background in Nuclear Medicine. His experience at Roswell Park Comprehensive Cancer Institute uniquely positions him to contribute to FAAS’s mission of ensuring site excellence.

 

 

 

 

How You Can Help

We invite programs and healthcare professionals to join us in spreading the word about FAAS. By recommending FAAS to companies seeking to conduct audits, you not only support the advancement of innovative treatments but also contribute to expanding patient access to these life-changing therapies. Companies can initiate the process of developing a customized assessment program via the Needs Assessment Form on the FACT Consulting Services website. Feel free to share this link!

FAAS represents a pivotal step towards optimizing site assessments and enhancing patient access to groundbreaking treatments. Together, let’s propel the healthcare industry forward and make a meaningful difference in patients’ lives.


Tata Medical Center is First Cellular Therapy Program in India to Earn FACT Accreditation

Posted in :: 2024 Volume 2 :: Tuesday, April 9th, 2024

FACT is pleased to announce that Tata Medical Center in Kolkata, India, received internationally recognized FACT accreditation. Directed by Jeevan Kumar, MD, MBBS, it is the first and only cellular therapy program in India to be recognized by FACT. Dr. Mammen Chandy, former Director of Tata Medical Center, committed years ago to enhancing quality throughout the program and attaining FACT accreditation. The program achieved accreditation February 29, 2024, for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation. Tata Medical Center is part of the FACT India Working Group, led by Nadim Mahmud, MD, PhD.

Dr. Mahmud states, “This marks a significant milestone for the FACT India Working Group and for India. We are encouraged by Tata Medical Center’s achievement in obtaining FACT accreditation, which demonstrates a commitment to quality and ensuring the best possible outcomes for patients undergoing stem cell transplants. We believe that other transplant centers in India will recognize the benefits and join us in pursuing FACT accreditation. I am indebted to Professor Mammen Chandy from Tata Medical Center for his wisdom in facilitating the process and advocating the need for FACT accreditation, not only for Tata Medical Center in Kolkata, but for all BMT centers in India.”

Dr. Kumar notes, “The FACT accreditation cements our commitment to provide the highest quality of patient care. It is recognition of our founding director’s vision to establish evidence based best practices in cellular therapy at Tata Medical Center. The unwavering support of the administration and our team’s hard work has resulted in successfully completing the accreditation process. It marks the inclusion of the first Indian center into the global consortium of accredited institutions. Even though the accreditation process was rigorous, it helped us to consolidate our strengths and identify opportunities for improvement. The FACT team has continuously supported us in this endeavor. The on-site inspection served as a peer-review by international experts and boosted the morale of our team members. As an active member of the FACT India Working Group, we are happy to share our experiences and quality improvement initiatives with like-minded centers in India and abroad.”

Dr. Phyllis Warkentin, FACT Chief Medical Officer, states, “Tata Medical Center’s achievement of FACT accreditation in Hematopoietic Cell Transplantation and Cellular Therapy as the first program in India to reach this milestone demonstrates its commitment to providing quality care for the patients it serves. FACT commends the leadership and staff of Tata Medical Center for their dedication and resilience in pursuit of accreditation, their contributions to the FACT India Working Group, and their leadership in the field and the region.”


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:

         

 

 


Current Quality Management Webinar Series on Embracing Change: Growing Your Cellular Therapy Services

Posted in :: 2023 Volume 4 :: Thursday, July 27th, 2023

 

 

 

 

 

The theme for Series 12 of FACT Quality Management Webinars is embracing change. Each webinar will equip organizations with practical strategies and insights to successfully incorporate a new service or product into your cellular therapy organization while ensuring compliance, optimizing patient outcomes, and driving continuous improvement.

There will be two parts for this series. Part I of the series in 2023 includes the following webinars:

Registration is available for each webinar individually using the links above, or bundle and save 15% on the full series! The bundle can be purchased at QM Series 12 Webinar Bundle.

 


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!


Quality Management Series 11: Corrective Action Plans

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

Implement and Assess Effectiveness of Corrective Action Plans
August 24, 2022

Join us on Wednesday, August 24, 2022, at 11:00 ET/17:00 GMT, for the FACT QM 11 Webinar: Implement and Assess Effectiveness of Corrective Action Plans. Presenters will discuss:

  1. Implementation of corrective action plans.
  2. Monitoring corrective action plans. Assessing the effectiveness of a corrective action plan.

Presenters:

Folashade Otebeye, MBChB, MPH
Fred Hutchinson

 




Kerri Hill, BSN, RN
UAMS Cancer Institute

Register now

 


Corrective Action Plans: Program Perspective
November 9, 2022

Join us on Wednesday, November 9, 2022, at 3:00 pm ET/21:00 GMT, for the FACT Quality Management Series 11 Webinar: Program Perspective. Presenters will discuss corrective action plans from the Clinical, Collection, Processing, and Cord Blood Bank programs’ perspectives.

Presenters:

John McCarthy, MD                                  
VCU Health


Leigh Gates, CPHQ
University of Colorado


Phillip Johnson, MMedSc(Path)
Queensland Cord Blood Bank at the Mater


Additional webinars in this series are open for registration at the following links. Advance registration and post-webinar recordings of all webinars in this module can be purchased at a discounted rate.

Register now

Other webinars in this series include:


Corrective Action Plans the Focus of this Year’s Quality Management Webinar Series

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

The 11th module of the Quality Management Series is all about corrective action plans.

The first webinar, hosted on February 26th, was, Overview of Corrective Action Plans. Dr. Carlos Bachier from Sarah Cannon Transplant and Cellular Therapy Program at Methodist Hospital in San Antonio, and Lisa Cantwell MHA, CPHQ from the Blood & Marrow Transplantation Program of the Holden Comprehensive Cancer Center at the University of Iowa, discussed the following:

  1. When a corrective action plan is needed
  2. The purpose of a corrective action plan
  3. Who should be involved
  4. Short term immediate corrective action, and long-term preventive correction action
  5. How to assess the effectiveness of a corrective action plan

Additional webinars in this series are open for registration at the following links. Advance registration and post-webinar recordings of all webinars in this module can be purchased at a discounted rate.


The X Factor: What is GxP and What Training is Required?

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration requires that physicians and staff have annual training in current GxP appropriate to the processes performed in accordance with Applicable Law. (See Standards CM3.3.4, C4.4.2.5, and D4.4.2.5).

What is GxP?

The Standards define GxP as, “Good practice following various quality standards and regulations. The “x” is variable, with further definition of good practices defined by different Applicable Law and industry standards. The type of work that is being performed will define which GxPs should be followed.”

Different facilities will follow different GxPs based on the activities they perform. These may include, but are not limited to, Good Manufacturing Practices (GMPs), Good Tissue Practices (GTPs), Good Documentation Practices (GDPs), Good Clinical Practices (GMPs), and Good Laboratory Practices (GLPs).

What GxPs require annual training per the Standards?

 FACT requires training in all GxPs that are required by law. Accredited facilities must determine which GxPs apply to the activities they perform and for the types of cellular therapy products for which the cells will be used. This includes an assessment of all activities and determination of which GxPs are required by law for each of those activities. Facilities must document this assessment so 1) the program has a defined list of GxPs that require training and 2) inspectors can verify appropriate training is performed.

All Apheresis Collection and Processing Facilities will have activities applicable to GTPs and GDPs. All Marrow Collection Facilities will have activities applicable to GDPs, but may also perform activities related to GTPs. Collection and Processing Facilities may also need to follow GMPs, GCPs, or GLPs. The extent and level of GMPs implemented is dependent on the type of manufacturing that is performed (e.g., manufacturing of allogeneic minimally manipulated HPC cellular therapy products verses investigational and licensed cellular therapy products).

How much training is required each year?

Comprehensive training on every aspect of GxPs each year is not expected; rather, there must annually be some training based on a GxP topic.

Many of the procedures performed by personnel already require training in GxPs to perform the work; therefore, GxP training is not required to be separate. However, documentation must provide evidence that the GxPs were included. For example, training in environmental control could include an overview of GTPs or GMPs, the relevant requirements based on the work to be performed, and the specific tasks performed by personnel.

Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards

Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual


Learning from Each Other: Accredited Organizations’ Advice for Preparing for FACT Inspections (Part 3)

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

By Stacy Freeburg, FACT Accreditation Coordinator

How do you maintain audits, various consent forms, and other documentation?

Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service

Our quality management system, Q-Pulse, has been fantastic for maintaining audits, documents, non-conformances, supplies, equipment, and now training courses.  We are a central system overseeing 2 pediatric FACT-accredited sites and 12 nationally accredited sites (National Association of Testing Authorities, Australia/National Pathology Accreditation Advisory Council [NATA/NPAAC]). Without this tool, we would not exist. It automates actions, creates workflows, and emails notifications. I really like how easy it is to modify drop downs to meet our requirements without information technology upgrades or database changes. It is also very intuitive for staff, which makes training and day-to-day use very easy. I used to work for the national body, NATA, and I saw a lot of very complicated software packages-at accredited sites. Many were not well used!

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute
and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

Maintenance of audits, consent forms, and labeling is assigned to various quality designees, as applicable. Our programmatic Standard Operating Procedures (SOPs) describe established processes for follow-up and reporting to ensure the audits are completed in a timely manner. SOPs dictate processes for consent updating and review. Check-off and time-out processes ensure labeling is completed per standards and regulatory guidance. The quality designees work with physicians, supervisors, and clinicians to maintain compliance with FACT standards impacting the daily duties of staff members. The integration into daily practice creates a quality-focused program, with built-in and evolving checks and balances throughout the program’s departments to ensure consistency of processes and procedures.

Share strategies for staying up to date on upcoming changes to the Standards and what tools you use to communicate those upcoming changes within your organization.

Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service

Generally, this is done via Q-Pulse. We have had specific training sessions across our network, which have focused on donor work-up, ISBT 128 labelling, and GMP requirements.

An Immune Effector Cell (IEC) Quality Manager focuses purely on IEC rather than both Hematopoietic Progenitor Cell (HPC) and IEC. This has assisted in developing IEC-specific SOPs and processes. This is such a growing area that I believe it needs individual attention.

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute
and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

Monthly meetings are conducted to discuss regulatory topics, including any updates to the FACT Standards. Key personnel from the clinical, collection, and processing facilities participate in the monthly meetings. Consistent monitoring of the FACT newsletter and disseminating pertinent updates occurs during these meetings. Note, our programmatic SOPs outline how updates need to be conveyed to the program, reviewed with the FACT Program Director, and distributed to the program through an appropriate conduit based on the impact and urgency of the change.

Stacy Freeburg, FACT Accreditation Coordinator, FACT Accreditation

Maintain a spreadsheet or utilize OneNote or a similar tool that crosswalks the FACT Standards to your SOPs. FACT provides an Excel download of all standards and related questions, called the Self-Assessment Tool, in the portal that can be used to prepare for the accreditation process. If a new edition of Standards is finalized during the organization’s accreditation cycle, organizations can use the crosswalk FACT provides to update its internal crosswalk to SOPs (available on the FACT website).

For additional information, download and view the educational recording, QM Series 8: The Document Control Process From Start to Finish (and Back Again!) (FACT), September 13, 2017.

Thank you to the following contributors for sharing their tips and lessons learned from their experiences at a FACT accredited program:

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute
and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service

Elisha Nixon, Quality Program Manager, Walter Reed National Military Medical Center, Murtha Cancer Center Research Program, Uniformed Services University of the Health Sciences, The Henry M. Jackson Foundation


Register for the FACT-JACIE and WBMT Webinar: Quality and Accreditation for Cellular Therapy: A Global Perspective

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021


Quality Management Series, Module 10: Validations

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

The Quality Management Series Module 10 includes four sessions focused on Validation including:

Validation Overview
Presented by Nicole Prokopishyn, PhD
August 19, 2020, 11:00 am ET, 15:00 GMT

Dr. Prokopishyn will discuss the difference between Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.

Register now

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 module to receive a 15% discount! QM Series Module 10: Validations


FACT Announces New Quality Management Series, Module 10: Validations

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

The Quality Management Series Module 10 includes four sessions focused on Validation including:

Validation Overview
Presented by Nicole Prokopishyn, PhD
August 19, 2020, 11:00 am ET, 15:00 GMT

Dr. Prokopishyn will discuss the difference between Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.

Register now

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 module to receive a 15% discount! QM Series Module 10: Validations


2020 FACT-ASTCT Quality Manager Engagement and Resiliency Survey

Posted in :: 2020 Volume 2 :: Monday, March 16th, 2020

 

Resilience is the ability to recover from or adjust easily to change.  Highly resilient individuals thrive in an environment of change. The Quality Manager’s capacity to be resilient during change, a constant in their work life, is a critical skillset.

Since 2017, the FACT Quality Management Committee and the ASTCT Administrative Directors SIG Quality Working Group have collaborated to identify opportunities to increase the QM’s resiliency During that year, the quality groups developed an anonymous survey to collect data on Quality Manager personal resilience and their perceived benefits of improved resilience. The survey included a validated “Brief Resilience Scale”2 (BRS) which quantitatively measures resilience (1 = low to 5 = high).

To assess possible work stressors, Quality Managers were queried about their responsibilities, program size/complexity, and the nature of interactions with others, e.g. direct supervisors. Respondents were also asked to rank selected resources for increasing resiliency.

Since that initial survey, results have been analyzed and presented as abstracts during TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR.  Additionally, survey findings have been used to identify resources to help, among others, build resilience through improved workplace communications, workload management.   This resources list was uploaded to the FACT website at:  http://www.factwebsite.org/WorkArea/DownloadAsset.aspx?id=1898.

It’s come time to reassess…Quality managers, we need you! 

The committees are reaching out more broadly to cellular therapy program and cord blood bank Quality Managers around the world requesting that you complete a follow-up survey.   This year’s anonymous survey takes approximately 20 minutes to complete.  The survey can be accessed at the web address or by scanning the QRS code included below.

 

https://www.surveymonkey.com/r/FACT-ASTCT2020QMResiliency

 

 

 

The FACT Quality Management Committee and the ASTCT Administrative Directors SIG Quality Working Group plan to analyze information provided by respondents later this year and publish early in 2021.


Final Webinar in the Quality Management Series, Auditing

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

February 5, 2020
3:00 pm ET, 20:00 GMT

Join FACT for the final webinar in the ninth Quality Management Series, Auditing.  Phillip Johnson, MMedSc(Path), Production Manager at Queensland Cord Blood Bank at the Mater, Sylvia Dulan, RN, MSN, MBA, PMP, HCT Regulatory and Quality Management Specialist at City of Hope Hematopoietic Cell Transplantation Program, and Ann Wilson, MHA, MT(ASCP)SB , Lab and Quality Manager at Scott & White Autologous Transplant Program, will give an overview of their program’s audit process and how they write audit reports.

Register now

The first three webinars within the module are available for download in the FACT store:

  1. QM Series 9: Auditing: Planning and Executing
  2. QM Series 9: Auditing: Summarizing and Evaluating the Data
  3. QM Series 9: Auditing: Performing follow-up to assess the effectiveness of the actions implemented on correcting the errors

Stay tuned for the next QM Series 10, Validations!  Topics include Validation Overview, Process Validation, Software Validation, and Program Perspectives on Validation.


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 


Education Events

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

Using an Electronic Platform for Accreditation Preparation and Continuous Readiness Webinar
Wednesday, June 26, 11:00 am ET
Webinar

This webinar will be on June 26, 2019 at 11:00 am ET and is FREE OF CHARGE. Trisha Deason, MHA, MSN, RN, NE-BC, Eryn Draganski, AGCNS-BC, OCN, and Jay Maningo-Salinas, PhD, RN, NE-BC, CPHQ, FACHE, from Mayo Clinic Arizona, have graciously agreed to share their tool designed in Microsoft OneNote to be used for continuous readiness and compliance with FACT requirements.

Collecting supporting evidence for accreditation standards can be a daunting task and include a tremendous amount of resources (e.g., paper, binders, charts). Workflows may be inefficient if duplication of efforts occurs across personnel and departments. Use of an electronic source provides an updated mechanism to gather, retain, and share evidence, as well as an organized approach to present all supporting documents to on-site surveyors. Presenters will provide step-by-step instructions on how to build a OneNote FACT e-binder and organize evidence to be used for continuous readiness and/or as a platform to deliver evidence to the FACT survey team.

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ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 1
Thursday, July 25, 11:00 am ET
Webinar

The first webinar in this two-part webinar series will be on Thursday, July 25, 2019 at 11:00 am ET.  Part one includes information from two centers regarding their journey to successful implementation of commercialized CAR T-cell products. Clinicians will address the challenges faced during the site on-boarding process, where they are in the process, commonly faced impediments to timely delivery of therapy to patients, and suggestions for centers initiating implementation of commercial CAR T-cell products. Topics in this webinar will include required training, maintenance of chain of custody, and mechanisms for reporting outcomes data. FACT accreditation will also be covered.

This is part one of two in the Centers’ Experience with Implementing Commercial CAR T-cell Products series.  Part two will take place in September of 2019 and will include the perspective of a hospital administrator in regard to the following:

  • Agreements with Manufacturers
  • Reimbursement
  • FACT accreditation

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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.

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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!

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

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will be in attendance to 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.

Two tracks are available for this workshop. The Inspector Track will provide FACT inspectors guidance on how to assess compliance with the Standards. The Applicant Track will give programs and facilities insight into how to comply with the Standards and demonstrate compliance.

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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