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cGMPs for the Transfusion Service - Part 2 2018 Program Overview

On September 24, 2018, the Blood Systems organization united under one shared name, Vitalant. Programs posted prior to that date may contain legacy branding.

Program Description

Although many may not be aware, Good Manufacturing Practices (cGMPs) apply to Transfusion Services as well as Blood Donor Centers, and personnel in Transfusion Services are expected to be trained in cGMPs.  This module examines the history of cGMPs, why they apply to Transfusion Services, and cGMP requirements as they relate to process control, procedures, documentation, deviation management and audit.

Learning Objectives

Upon completion of the workshop, the participant will be able to:

  • Define GMPs related to process control, procedures, and documentation.
  • Define GMPs related to procedures and documentation
  • Describe what is needed to ensure that procedures comply with GMPs
  • Explain good documentation practices
  • Define GMPs related to deviation management and audits
  • Identify the elements of a deviation management program
  • Describe a process for managing audits and the results of audits

Level of Instruction

  • Basic to Intermediate

Speaker Credentials

Judy Sullivan, MS, MT (ASCP) SBB is a consultant for Quality Source, a division of Blood Systems, Inc.  Prior to her position at BSI, she was the manager of accreditation programs at AABB, a position she held for nine years.  Judy has worked as a technologist and marketing specialist for Ortho Clinical Diagnostics, a reference technologist at the American Red Cross, MO-IL Region, and the supervisor of the reference laboratory in the department of transfusion medicine at the National Institutes of Health.  She is an adjunct professor at George Washington University.

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

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