Course Outline
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- The Law and Regulations
- Introduction
- FDA Registration and Exemptions
- Current Good Manufacturing Practice (cGMP) Defined
- Donor versus Transfusion Service
- Redundancy
- Section Summary
- Good Manufacturing Practices apply to:
- Which of the following activities could a facility perform and still be exempt from registration and submission of a list of components manufactured?
- General Good Manufacturing Practices Correlated to CFR Parts Specific to Transfusion Services Part 211
- General Biological Good Manufacturing Practices Part 600
- 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...
- Current Good Manufacturing Practices for Blood and Blood Components Part 606
- General Biological Product Standards Part 610
- Additional Standards for Blood and Blood Components Part 640
- Overview of Part 640
- Reissue of Blood
- Red Blood Cells
- Platelets
- Plasma
- Cryoprecipitate
- 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...
- Additional Standards for Diagnostic Substances for Laboratory Tests Part 660
- 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 to include Medical Laboratory Scientists (MLS), Medical Laboratory Technicians (MLT), and transfusion medicine administration/management. It can also be useful for MLS and MLT students.
Author Information: Suzanne H. Butch, MA, MLS(ASCP)
CM, SBB, DLM 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 Bachelor's degree in Medical Technology from the University of Michigan, a Master's Degree in Management and Supervision from Central Michigan University, and Certifications as a Specialist in Blood Bank, Quality Audit, and 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 Information: Jules Zinni, MS, MLS(ASCP)CM, MBCM, SBBCM is the Laboratory Supervisor of Special Testing at Endeavor Health in Elmhurst, Illinois.
