GxP Lifeline

 

  • Defining GxP Training / Learning: Part 1

    6 October, 2010 Nancie E. Celini, GxP, Learning Program Lead

    The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. While this may seem "elementary" to some of you, many people may not know what this means. So let's define it because when we refer to "GxP training" you need to have the right context.

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  • Data and Content Migrations: Minimizing the Risk

    David Katzoff, Managing Director of Product Development and Chief Architect for Valiance

    Compliance and business risk plays a significant role in the implementation methodologies of corporate information systems. Further, the compliance and business risks associated with these corporate information systems are, in general, well known. However, as part of the implementation process many of these information systems will be populated with legacy data. The compliance and business risks associated with migrating this legacy data and content into a new system are not necessarily understo

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  • Conducting a Clinical Trial in Europe from the Perspective of a U.S. Virtual Company

    10 September, 2010 Dr. John McLane, VP Clinical and Regulatory & COO, Clinquest

    A common biotech business model is to have a lean and fast virtual organization. These organizations are established with experienced professionals who have a wide breadth of entrepreneurial experience and experience within the pharmaceutical, biotechnology or even medical device sectors. These organizations also have innovative products that are to be developed to the next inflection point, which is usually a step to reduce further developmental risk. The product can then be moved on toward r

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  • Computer System Validation: FDA Inspections

    6 October, 2010 Michael J. Gregor, President, Compliance Gurus, Inc.

    Is your organization ready for an inspection of your Computer System Validation program? In this article, I will offer some key tips on how to prepare for an inspection of your computer system validation (CSV) program. Often times, the FDA comes to inspect your facility for reasons other than your CSV program. However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection. A

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  • The Future is Now for Computer-Based Quality Systems

    John C. (Jack) Garvey, Esq., Principal Compliance Architects LLC

    Especially for users of paper-based quality systems, it's hard to believe that it's been close to 25 years since companies first began using computers to facilitate their regulatory obligations for maintaining quality systems. Throughout this 25-year period, there has been extraordinary progress in technology, features, functionality, and scope of the solutions; along with an equal amount of disappointing results and unrealistic expectations. Many companies over the years have spent small (and

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  • Change Control - Continuous Quality Improvement in FDA and ISO Environments

    15 November, 2010 Jason Clegg, Marketing Director, MasterControl, Inc.

    Globalization of the marketplace has greatly intensified competition and has increased the pressure on manufacturers to develop innovative, high-quality products faster and at a lower cost. To stay competitive, manufacturers must be quick to meet customer demands and even quicker in adapting to changing market conditions.

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  • 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

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  • 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.

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  • 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.

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  • 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!"

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  • 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.

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  • 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.

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  • 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.

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  • 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

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

    18 April, 2017 MasterControl

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

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  • 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.

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  • 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.

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  • 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

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  • 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

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  • HCT/P Inspections: Most Common Deviations

    13 April, 2017 MasterControl

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

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