FACT Inspector Qualifications

Cellular Therapy Inspector Categories

Clinical Hematopoietic Cellular Therapy Inspector

• Licensed physician (medical degree).
• At least two years experience in hematopoietic progenitor cell transplantation.

Clinical Immune Effector Cellular Therapy Inspector

• Licensed physician (medical degree).
• Experience in cellular therapy product administration, including experience with immune effector cell protocols.

Clinical Regenerative Medicine Cellular Therapy Inspector

• Licensed physician (medical degree).
• Experience in cellular therapy product administration, including experience with investigational new drug (IND) or clinical research protocols.

Marrow Collection Inspector

• Licensed physician (medical degree).
• Completed formal fellowship training in marrow collection or at least one year experience in marrow collection as a director or physician.

Apheresis Collection Inspector

• Relevant doctoral (M.D. or Ph.D.), nursing, or biological science degree.
• Completed formal fellowship training in apheresis or at least one year experience in cell collection by apheresis as the director, physician, or individual with direct supervision of apheresis personnel.

Cellular Therapy Processing Inspector - Minimal manipulation of HPC

• Relevant doctoral (M.D. or Ph.D), biological science, or medical technologist degree.
• At least two years experience as a director or medical director of a cell processing facility or as an individual with direct supervision of processing personnel.
• Experience processing hematopoietic progenitor cells.

Cellular Therapy Processing Inspector - More than minimal manipulation of any type of cell

• Relevant doctoral (M.D. or Ph.D), biological science, or medical technologist degree.
• At least two years experience as a director or medical director of a cell processing facility or as an individual with direct supervision of processing personnel.
• More than minimal manipulation of any type of cell: Experience processing cellular therapy products with more-than-minimal manipulation under IND or equivalent requirements.

Cord Blood Bank Inspector Categories

Cord Blood Bank Inspector

• Relevant doctoral (M.D. or Ph.D.) degree.
• At least two years experience in cord blood banking or transplantation.

Cord Blood Bank Collection Inspector

• Relevant doctoral (M.D. or Ph.D), nursing, or biological science degree.
• At least one year experience as a cord blood bank director or individual with direct supervision of cord blood collection personnel.

Cord Blood Bank Processing Inspector

• Relevant doctoral (M.D. or Ph.D), biological science, or medical technologist degree.
• At least two years experience as a director or medical director of a cord blood bank cell processing facility or as an individual with direct supervision of cord blood bank, cord blood processing, or cellular therapy product processing personnel.