File AdministeringFiles.zip (622.686 KB)
For the past several months, you have been working with Teeanna Brisco, Ph.D. and Ndia Jones, M.D. to gather research and information for a grant. You are now ready to assemble the information into one document, and review the document for polishing. In the attached, zipped folder, you will see all of the files you have collected over several months. Some will be used in the grant application document, some will not. Your job is to use the information below, to assemble the grant application into one document. Drs. Brisco and Jones have given you an outline for the contents of the grant application document, below. Start a new Word document. Insert the files, in order, and with correct formatting and layout. Then, review the entire document’s spelling, grammar, formatting, or layout mistakes and fix any errors. Like a real-world project, the doctors have given you enough information to complete the work without creating a time-consuming step-by-step guide. You must use your skills, knowledge, and best judgment to complete the work. Also replicating a real-world project, the doctors have very busy schedules and cannot answer every question that pops up. You will have only one opportunity to asks questions, if needed, before submitting. If you have questions, you must:
Send all questions in one email message to the instructor
Use the subject line: Internship Administering Files Project
Within the body, write your question(s) so that the recipient knows exactly what information you need. You will receive only one response, so be clear. You will not get a second chance to submit questions.
Dont worry, you’ve got this! Use your professional judgment to produce a final document that is ready for submission to the World Health Organization.
Grant Application Instructions
Attached Files:
File Grant Application Instructions.docx (31.819 KB)
Dr. Brisco and Dr. Jones Grant Application. Assembly the information, into one MS Word document, in this order:
Introduction
International Biological Reference Preparations
Glossary
General considerations
Range of products made from human blood and plasma
Composition of human plasma
Pathogens present in blood and plasma
Measures to exclude infectious donations
Appropriate selection of blood/plasma donors
Screening of blood/plasma donations for infectious markers
Epidemiological surveillance of donor population
Strict adherence to Good Manufacturing Practices
Post-donation events
Production of plasma for fractionation
Methods used to obtain plasma for fractionation
Characteristics of plasma for fractionation
Premises and devices for collection of plasma for fractionation
Blood/plasma collection process
Separation of plasma
Freezing of plasma
Storage of plasma
Compliance with plasma fractionator requirements
Release of plasma for fractionation
Packaging of plasma
Transportation of plasma
Recall system
Quality assurance system and Good Manufacturing Practices
Organization and personnel
Documentation system
Premises and equipment
Materials
Validation program
Quality monitoring data
Virology safety testing
Electronic information system
Storage and transport
Change control system
Quality assurance auditing
Defect reporting system
Quality agreement between blood establishment and fractionator
Blood/plasma establishment audit and inspection
Regulatory control of plasma for fractionation
Role of national regulatory authority
Establishment license and inspections
Impact of Good Manufacturing Practices
Inspections
Authors
References
Appendix 1Plasma products and clinical application appendix 2Donor selectionAppendix 3Donor immunization and plasmapheresis for specific immunoglobulinsAppendix 4Contract plasma fractionation programAppendix 5Technical points to consider in establishing plasma specifications criteria and obligations between blood establishment and plasma fractionator
