• The Challenges of Change Control

    Kenneth Christie, COO, VTS Consultants, Inc.

    The term "change" is something that we all experience both in life and in our business. While some of us might embrace it and seek the challenges, there are often more that do not like it and are resistant to the implications that change may have. The big difference between the two attitudes is that in life, we face the change, accept it and move on. We do not formalize the event by a series of documents, reviews, evaluations and approvals. In regulated industries, such as pharmaceuticals, biote

    Full story
  • Certification and Advanced Degrees: Are They Worth It?

    12 July, 2011 John A. Challenger, CEO, Challenger, Gray & Christmas, Inc.

    Note: A long-running discussion in the LinkedIn ASQ Group about the significance of certification led us to ask this employment expert about the value readers receive from advanced degrees and certifications, particularly in a highly-competitive job market like life sciences.

    Full story
  • How to Build a Business Case for a Quality Management System

    14 June, 2011 Jon Nugent, Managing Director of Client Services, Business Intelligence Solutions

    It is impossible for FDA-regulated manufacturers to conduct business without paying close attention to regulatory compliance.

    Full story
  • AUG Writing and Maintaining SOPs: Drudgery or Delight?

    18 April, 2017 Katy McMullin, Senior Professional Services Consultant at MasterControl

    "SOPs! We don't need no stinking SOPs!"

    Full story
  • The Buzz on West Nile Virus

    13 April, 2017 Robyn Barnes

    Summer's onset brings that familiar buzz of the bug we all love to hate: the mosquito. The itch, the swelling, the unsightly bumps on the skin---not to mention the scratching---are the annoying price we pay for outdoor fun.

    Full story
  • Whats in Your Toolbox? Choosing the Right Tool for Quality Improvement

    14 April, 2017 Bonnie Messinger

    Quality improvement tools are like any other tool set. Each basic tool has a brood of new and improved versions intended for increasingly specialized applications. A seasoned facilitator may have literally hundreds of tools at her disposal. However, finding a few basic favorites and learning them well is sufficient for most applications.

    Full story
  • Tissue Tracking Failures and Lessons Learned - Hope for the Future

    10 August, 2010 Scott A. Brubaker, CTBS, Chief Policy Officer, American Association of Tissue Banks

    Note: The opinions expressed by the author in this manuscript are not necessarily representative of the membership of the AATB.

    Full story
  • Tissue Banking - Good Tissue Practices GTP - Regulations, Operations and Medical Oversight

    13 April, 2017 MasterControl

    An Interview with Ted Eastlund, M.D., by Robyn Barnes

    Full story
  • Writing and Maintaining SOPs - Sep 09 - B&B Article

    18 April, 2017 MasterControl

    "SOPs! We don't need no stinking SOPs!"

    Full story
  • Sizing Up Staff Competency Article

    13 April, 2017 MasterControl

    Training employees to perform tasks in a laboratory or technical environment is critical to the success of any regulated business. Assessing employee skill levels is one way to see if employees are comprehending what they are learning.

    Full story
  • San Antonio Hospital Aims to Perform "Bloodless" Surgeries

    WOAI-TV (NBC) San Antonio

    Northeast Baptist Hospital in San Antonio, Texas has adopted a perioperative blood management program, aiming to perform 90% of surgeries without blood transfusions. The hospital has received support from the South Texas Blood & Tissue Center, which says bloodless facilities help ease the demand for blood and tissue donations.

    Full story
  • The Value of the Quality Risk Management Approach to Validation as Prescribed by ISBT Validation Guidelines V2

    ISBT Validation Guidelines V2

    According to the ISBT-Guidelines For Validation of Automated Systems in Blood Establishments (Guidelines)1 the blood bank is responsible for the regulatory compliance of the automated/computerized systems used at the Facility and MUST have a Quality Management System (QMS). Blood Banking organizations around the world support these guidelines, which prescribe that full validation of the computerized system be required for systems critical to product and quality (information management, storag

    Full story
  • QMS Pains in the Blood and Biologics World

    13 April, 2017 Rob Carpenter, Product Manager, Customer Relationship Manager and Blood and Biologics Expert, MasterControl

    Maintaining a quality system within a blood and biologics organization is a very resource-intensive endeavor. Changes resulting from new regulations, new and updated procedures, new techniques, changes in suppliers and supplies, new and enhanced safety practices, and the like, all result in a massive amount of change that must occur across the organization. Managing these changes in turn requires the assignment of multiple resources across multiple areas of an organization. These are just the qu

    Full story
  • HCT/P Inspections: Most Common Deviations

    13 April, 2017 MasterControl

    Total of 36 Product Recalls Last Year for HCT/P Sector

    Full story
  • Stop the Madness! Process Control Essentials for Effective Continual Improvement

    Lisa M. Walters, Ph.D., Principal Officer of Healthy Solutions Quality Consulting, LLC

    It is a dark and stormy night. Your facility is readying for what promises to be a challenging third-party review. You, the Quality Manager, along with your organization's General Manager, are reviewing a variety of the process monitoring data reports to prepare for the upcoming "grilling." One such report provides information regarding response times to the central monitoring alarm system, specifically for the reagent storage refrigerator.

    Full story
  • The Value of Performing a Good ValidationIn Transfusion Medicine

    Robin Nozick, MT(ASCP) CTO and Founder of R.F. Nozick and Associates

    The blood establishment bears the responsibility for the regulatory compliance of the automated/computerized systems used. Full validation of the computerized system is required for systems critical to product and quality (information management, storage, tools for operational decision-making, and control). The Quality Risk Management approach to validation advocated by GAMP 5 and ICH Q9, a life cycle approach within the QMS, and the use of risk assessments to define the validation strategy for

    Full story
  • Minimizing the Risk of Donor Disease Transmission

    4 January, 2011 Emily Blumberg, Professor of Medicine and Program Director for the Infectious Diseases Fellowship Training Program, University of Pennsylvania

    Each year in the United States, nearly 30,000 people receive the opportunity to save, extend or enhance their lives through the human gift of organ donation. Of those, roughly three-fourths of the organs transplanted come from deceased donors.

    Full story
  • A Myriad of Documents - Is there Control?

    Marianne A. Silva, MS, MT(ASCP)SBB, CQA(ASQ)

    Document control is an issue for every laboratory. The words in the requirements seem so simple: control your documents. How can so much effort be involved in three words?

    Full story
  • Blood Bank ISBT 128 Implementation - Blood Industry

    David Linnemeyer, BS, MT(ASCP)SBB), Manager, East Jefferson General Hospital Blood Bank

    My own blood bank's ISBT implementation was not quick or easy. If I could do everything again, I would do things quite differently. Hopefully a review of my own mishaps will help you plan your own ISBT implementation more effectively.

    Full story
  • Legal Risks Affecting Blood Banks

    Cathy Burgess, Counsel, Crowell & Moring, LLP

    Blood banking is a high risk business. Some risks are obvious; others are not well understood. This article is by no means a comprehensive analysis of risks affecting blood banks. It identifies certain high risk areas and makes recommendations about risk mitigation, but is not intended to provide legal advice.

    Full story