Abstract
The complex nature of cell therapy manufacturing requires well-trained, competent professionals. Training is essential to ensuring the quality of the products and services provided by biologic manufacturing facilities. Mandated by the U.S. Food and Drug Administration (FDA) in Good Manufacturing Practices (GMPs) and Good Tissue Practices (GTPs) regulations, training is as much a requirement as it is the right of passage to becoming a productive and skilled employee. This chapter describes the development and implementation of a training program for cell therapy product manufacturing staff.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Food and Drug Administration. Current Good Manufacturing Practice for Finished Pharmaceuticals. Federal Register 1978; 43: 45076.
Food and Drug Administration. Current Good Tissue Practice for Human Cell, Tissue and Cellular and Tissue Based Products Establishments; Inspection and Enforcement. Federal Register 2004; 69: 68612–68688.
Baldrige National Quality Program. http://www.quality.nist.gov/index.html.
American Society for Training and Development. The ASTD Technical and Skills Training Handbook. Leslie K. ed. McGraw-Hill, Inc., New York, 1995.
AABB. Standards for Cellular Therapy Product Services. 3rd edition. AABB, Bethesda, MD, 2008.
FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration. 4th edition, October 2008.
Vesper JL. Defining Your GMP Training Program with a Training Procedure. BioPharmaceutics 2000; 13(7): 28–32.
Lindeman EC. The Meaning of Adult Education. New Republic, New York, 1926.
Amato HK, Konin JG, Brader H. A Model for Learning Over Time: The Big Picture. Journal of Athletic Training 2002; 37: S236–S240.
Yelon S, Sheppard LM. Instant Lessons. Performance Improvement Quarterly 1998; 37: 15–20.
Heinrichs KI. Problem-Based Learning in Entry-Level Athletic Training Professional-Education Programs: A Model for Developing Critical-Thinking and Decision-Making Skills. Journal of Athletic Training 2003; 37(4): S189–S198.
Designing a Training Lesson Plan. GMP Institute a division of ISPE. June 1998. http://www.gmp1st.com/trtp/trtp0698.htm.
Learn H. Web-Based Programs Work for the Lab Manager. Medical Laboratory Observer August 2005; 37(8): 38–41.
Lee C. Personnel Training and Competency. Cytotherapy 1999; 1(6): 493–508.
College of American Pathologists. Laboratory Accreditation Program. Transfusion Medicine Checklist. September 27, 2007. http://www.cap.org/apps/docs/laboratory_accreditation/sample_checklist.pdf
George KA. The Right Way: Staff Training and Competency Assessment. Medical Laboratory Observer 1996; 28(12): 44–47.
Haun DE, Leach AP. Performing Poorly But Testing Perfectly. Clinical Laboratory Management Review 2003; 17(2): 85–87.
Tiehen A. Competency Assessment: Establishing a Program. Clinical Laboratory Management Review 1999; 13: 275–285.
Health Care Financing Administration. Medicare, Medicaid, and CLIA Programs. Regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Federal Register 1992; 57: 7002–7186.
Sharp SE, Elder BL. Competency Assessment in Clinical Microbiology Laboratory. Clinical Microbiology Review 2004; 17(3): 681–694.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2009 Springer Science+Business Media, LLC
About this chapter
Cite this chapter
Kadidlo, D. (2009). Staffing, Training, and Competency. In: Gee, A. (eds) Cell Therapy. Springer, Boston, MA. https://doi.org/10.1007/b102110_11
Download citation
DOI: https://doi.org/10.1007/b102110_11
Published:
Publisher Name: Springer, Boston, MA
Print ISBN: 978-0-387-89583-3
Online ISBN: 978-0-387-89584-0
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)