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Inspector Bulletins

Inspector Bulletins are exclusively available to FACT inspectors to develop and enhance inspection skills. The bulletin shares commendable inspector practices, updates on FACT requirements, and suggestions for improvement. New editions are distributed to inspectors monthly via email. Inspectors who do not receive these email messages should notify the FACT office at fact@factglobal.org.

2021

May

  • Inspecting Collection Centers for NMDP Products

March

  • Understanding Cultural Differences and Organizational Behavior During the FACT Inspection
  • International Inspections

January

  • The Importance of the Inspection Team Leader
  • Resuming FACT Inspections

2020

December

  • Performing Immune Effector Cell Inspections
  • Inspector Satisfaction Survey

October

  • Writing Concise Citations
  • Virtual Inspections

September

  • Data Management
  • Inspector Spotlight

August

  • Outcome Analysis
  • Clinical Outcome History

July

  • FACT Mentor and Trainee Responsibilities
  • Definition of “Affix”

June

  • Update for HRSA-contracted Cord Blood Banks
  • Using the TRACER METHODOLOGY to Assess Compliance

May

  • FACT updates on Covid-19
  • Inspector Reimbursement

2019

  • We Need You!
  • Inspector Resources
  • Inspection Agenda
  • Pre-Inspection Review
  • Required Inspector Test
  • Completing the Inspection and Accreditation Process: A New Opportunity for Inspectors
  • Writing a Clear, Concise Inspection Report

2018

December

  • Writing a Clear, Concise Inspection Report
  • Inspector Thank You!

October

  • FACT Accreditation Portal for Inspectors
  • The Power of Inspector Recruiting
  • Post-Inspection Responsibilities
  • Assessing Compliance with B9.1: Data Management
  • New Accreditation Portal Training

May

  • ISBT 128 Coding and Labeling
  • FACT Webinar
  • Verifying Implementation of REMS at Clinical Programs
  • REMS-related Questions Added to FACT Documents
  • Requirements for Qualifying Third-Party Manufacturers of Cellular Therapy Products Regulated Under U.S. INDs or BLAs
  • Exceptional Release for Investigational Cellular Therapy Products

2017

  • Audits vs. Outcome Analysis
  • Audits Required by FACT Standards
  • Qualifying Manufacturers of Licensed Cellular Therapy Products
  • New Inspector Handbook Mobile Application
  • Audit Reports
  • IEC Inspectors Needed
  • Staying On-Site the Entire Inspection Day
  • Inspector Workshop Training Presentations Available
  • Changing Employers
  • Updating Your FACT Profile
  • Arranging Travel
  • Inspector Resources
  • FACT Inspection Information at Your Fingertips
  • Accessing Documents

May

  • Committing to Performing an Inspection
  • The Inspection Team
  • Immune Effector Cells
  • The Basics of Continuing Education
  • Examples of Appropriate Continuing Education Activities

2016

  • Inspector Trainee and Mentor Responsibilities
  • Submission of Inspection Materials
  • Inspector Travel
  • Reimbursement Reminders
  • Confidentiality
  • Successful Inspection Processes
  • Cultural Awareness
  • Differences in Body Language
  • Answering Challenging Questions
  • Be a Good Representative of FACT
  • Handling Unforeseen Complications of Inspections
  • Qualification of Reagents

June

  • Inspecting All Elements of an Organization
  • The Facility Tour

May

  • Performing Two Inspections Per Year
  • Importance of Volunteer Inspectors
  • Inspector Educational Resources
  • Upcoming Educational Events
  • Pre-Inspection Review
  • CB Standards to be Published Soon
  • Tracer Methodology for Inspections
  • 6th Edition HCT Standards Test
  • The Inspection Report
  • Closed versus Open Ended Questions

2015

  • Mentor and Trainee Responsibilities
  • Inspector Quick View

November

  • Navigating the Exit Interview
  • Exit Interview Quiz

October

  • Accessing Important Documents
  • 6th Edition Cellular Therapy Standards Inspector Test

September

  • Commendable Practices
  • Submitting RFIs

August

  • The Inspection Evaluation
  • Audits of Inspection Process

July

  • Building Rapport
  • Email Correspondence

June

  • First Impressions
  • Conduct

May

  • Inspection of Electronic Record Systems
  • Post-Inspection Responsibilities

April

  • Advance Communication with the Inspection Team
  • Continuing Education Requirements for Key Personnel

March

  • Challenging Situations
  • Remaining On-Site For Entire Inspection Day

January

  • FACT Resources
  • Writing Citations

2014

December

  • Exit Interview
  • Utilizing Travel Time

November

  • Inspector Assignments
  • Inspection Tour Tips

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