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Current Good Manufacturing Practices for Transfusion Services (Online CE Course)

(based on 180 customer ratings)

Author: Suzanne H. Butch, MA, MLS(ASCP)CM, SBB, DLM
Reviewer: Barbara Cebulski, MS, MLS(ASCP)

Good manufacturing practices lead to final products or services that consistently meet appropriate specifications and compliance with defined regulations. The main goal of good manufacturing practices is to prevent adulterated products from entering the market place.



This course focuses on transfusion services and the practices related to the manufacturing of blood and blood components. These practices are correlated to the Food and Drug Administration's (FDA's) current good manufacturing practices (cGMP) that are discussed in Title 21 of the US Code of Federal Regulations.



Laboratory personnel who review the cGMP sections of the Code of Federal Regulations (CFR) ensure their transfusion services departments provide safe products that are in compliance with the FDA regulations.

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Continuing Education Credits

P.A.C.E.® Contact Hours (acceptable for AMT, ASCP, and state recertification): 2 hour(s)
Course number 566105, approved through 9/1/2018

Objectives

  • Explain what constitutes good manufacturing practices for transfusion services.
  • Locate current Good Manufacturing Practices Regulations (cGMP) in the US Code of Federal Regulations.
  • Identify regulations applicable to situations encountered in the transfusion service laboratory.

Customer Ratings

(based on 180 customer ratings)

Course Outline

Click on the links below to preview selected pages from this course.
  • The Law and Regulations
  • 211 General Good Manufacturing Practices Correlated to CFR Parts Specific to Transfusion Services
  • 600 General Biological Good Manufacturing Practices
      • Addresses and Definitions
      • Shipment Temperatures
      • Establishment Inspections
      • Annual Reporting
      • Section Summary
      • A transfusion service that does not manufacture blood components may be inspected by which of the following organizations for compliance with good man...
  • 606 Current Good Manufacturing Practice for Blood and Blood Components
      • Current Good Manufacturing Practices (cGMP) For Blood and Blood Components
      • Standard Operating Procedures
      • Container Label
      • Additional Container Labeling Requirements
      • Specific Label Statements
      • Machine-Readable Label
      • Emergency Labeling
      • Autologous Labeling
      • What additional information is required on a label or tie tag of an autologous unit that is not required on the container label of blood or blood comp...
      • Compatibility Testing
      • Deviation Reporting
      • Section Summary
      • Which of the following scenarios would require that a biological product deviation be reported to the FDA?
  • 610 General Biological Product Standards
      • Testing for Communicable Diseases: 21CFR Part 610
      • Donor Deferral & Lookback
      • Dating Period of Blood Components
      • Section Summary
      • Which of the following activities would require that a label be added to the blood label indicating the name and location of a second manufacturer?
  • 640 Additional Standards for Blood & Blood Components
      • Title 21 Part 640 Overview
      • Reissue of Blood
      • Red Blood Cells
      • Platelets
      • Plasma
      • Cryoprecipitate
      • 640.120 Alternative Procedures
      • Section Summary
      • A platelet donor can donate by apheresis to a specific recipient who does not meet normal donor requirements if a licensed physician has determined th...
  • 660 Additional Standards for Diagnostic Substances for Laboratory Tests
      • 21CFR 660.20 Blood Grouping Reagents
      • Section Summary
      • The specifications for antibody screening cells are found in:
      • Conclusion
  • References
      • References

Additional Information

Level of instruction: Intermediate
 
Intended audience: Laboratory personnel who are involved in the production and processing of blood and blood components, including compatibility testing. This course is also useful for Medical Laboratory Science (MLS)  students and all MLS, MLT, and MT personnel who would like to maintain their knowledge and skills in transfusion medicine.
 
Author: Suzanne H. Butch, MA, MLS(ASCP)CM, SBB, DLM is currently working on special projects for the Department of Pathology at Michigan Medicine in Ann Arbor, Michigan. She formerly worked in Quality Assurance in the Department of Pathology and as the Administrative Manager for Healthcare, Blood Bank & Transfusion Service at the University of Michigan Hospitals and Health Centers in Ann Arbor, Michigan. She holds a Bachelors in Medical Technology from the University of Michigan, a Masters Degree in Management and Supervision from Central Michigan University, and Certifications as a Specialist in Blood Bank, as a Quality Audit, and as a Diplomate in Laboratory Medicine. She has edited books and written numerous book chapters and articles and has been invited to present numerous lectures in the field of computerization in the blood bank, automation, and transfusion medicine.
Reviewer: Barbara Cebulski, MS, MLS(ASCP) has over 40 years of experience in the medical laboratory profession as a technologist, section supervisor, and laboratory manager. She was an Inspection and Technical Specialist for nine years with the College of American Pathologists in the Laboratory Accreditation Program and, until her retirement in 2015, was Program Director for MediaLab, Inc. Barbara holds a Masters in Instructional Technology from Georgia State University.
 
Course content: This course reviews good manufacturing practices that apply to Transfusion Services and correlates these practices with the regulations that are part of Title 21 of the US Code of Federal Regulations. Laboratory staff in the Unit

shutterstock 277447430
Autologous Unit
Photo by Suzanne Butch
Event Report Form
On-Line Biological Product Deviation Report
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shutterstock 277447430


Autologous Unit
Photo by Suzanne Butch


Event Report Form


On-Line Biological Product Deviation Report