Session Information
AABB Annual Meeting and CTTXPO 2010
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Validation Plans
Track : QE- Quality Education
Program Code: 9110-QE
Date: Saturday, October 9, 2010
Time: 10:30 AM to 12:00 PM  EST
Location: 310
DIRECTOR :
Merilyn Wiler, MT(ASCP)SBB, MA Ed, Customer Regulatory Support Specialist, CaridianBCT
MODERATOR :
Merilyn Wiler, MT(ASCP)SBB, MA Ed, Customer Regulatory Support Specialist, CaridianBCT
SPEAKER (S):
Kathleen Hopping, BS, CQA(ASQ), Director Compliance & Regulatory Affairs, Blood Systems, Inc.
Validation Protocol: Automated Collection Systems
Deborah F. Dumont, MT(ASCP)SBB, Quality Specialist, Dartmouth-Hitchcock Medical Center
Equipment Qualification/Process Validation
Robin Nozick, MT(ASCP), Consultant, RobinCares Health IT
Validation of a BECS: Validation Necessary to be Safe!
Description
Everyone knows a validation plan must contain an IQ, OQ, and PQ section, but within each section exactly what data must be presented, how detailed must the information be, and how do you organize it so that it is easy for the reviewer? Since a picture can be worth a thousand words, three presenters have agreed to share examples of their best validation plans and data summaries. Emphasis will be on organization of data, clarity and depth of content. One example for a piece of lab equipment, one for software, and one for a collection device will be presented.

  • Share examples of well formatted/organized validation plans and validation data summaries.


CE CategoryCE Value
California Clinical Laboratory Personnel 1.5
California Nurse 1.8
Florida Laboratory Personnel 1.8
General Attendee 1.5
Physician 1.5
Please note: Continuing education (CE) credit is available for online offerings only. Individuals that purchase CD-ROMs will not receive CE credit for the programs they view.
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