Post Donation Information and the FDA Guidance Memo Program Overview
Program Description
This session will discuss the requirements of the FDA Memorandum on Post Donation Information (PDI). It will discuss actions to be taken by blood centers and transfusion services when market withdrawal of blood products is necessary as a result of a receipt of PDI. The most common PDI reports will be presented along with the potential risks to the recipients and recommended actions to be taken for any affected blood products.
Learning Objectives
Upon completion of the workshop, the participant will be able to:
- Identify and be familiar with the FDA Memorandum requirements on Post Donation Information (PDI)
- Name the most frequent causes for Post Donation Information (PDI)
- Know the actions to be taken when notified of a PDI Market Withdrawal
Level of Instruction
- Basic
P.A.C.E. Statement
Blood Systems, Inc. is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program
In 1977, P.A.C.E.® was established by the American Society of Clinical Laboratory Science (ASCLS) to stimulate and serve as the quality assurance mechanism for continuing education programs offered to clinical laboratory professionals. ASCLS strongly supports continuing education opportunities to increase and enhance professional knowledge and ongoing proficiency. P.A.C.E.® ensures that the continuing education programs offered to clinical laboratory professionals maintain high standards of quality and professional acceptability.
Contact hours
- Completion of this program will provide 1.0 contact hour of P.A.C.E. continuing education credit.
Speaker Credentials
Brenda Heiman, MT (ASCP) SBB, HP has worked for Blood Systems for the past 18 years. The first 15 years she worked at United Blood Services blood center in Billings, MT. She was the Technical Director, overseeing technical activities of the blood center. Brenda has spent the last 4 years working in the Manufacturing Processes Department of BSI's corporate offices developing validation protocols and procedures, implementing new technologies and providing consultation to UBS centers nationwide.
Technical Requirements and Assistance
To view the program material, you need a computer with a supported web browser and a dial-up or better internet connection. The supported operating systems and web browsers are:
Operating Systems
- Windows 2000, XP, Vista, Windows 7
- MacOS X 10.4 or later
- Linux 2.6 with KDE or Gnome
Web Browsers
- Internet Explorer 6 or later
- Firefox 2 or later
- Safari 3 or later
- Opera 9 or later
Technical Support
- Email: Contact Us
- Telephone: 1-888-376-1260
Content Questions
- Please contact Brenda Heiman at (480) 675-5466 for questions regarding this program.
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P.A.C.E. is a registered trademark of American Society for Clinical Laboratory Science