• Phamaceutical Companies Have to Increase Reliance on Technology - Did You Know?

    13 April, 2017 MasterControl

    Compliance with FDA’s eCTD requirements need not be a burden for any size company when “renting” a solution is just as effective as making the investment to buy a solution.

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  • Did You Know?

    13 April, 2017 MasterControl

    St. Louis, Mo., as the number of organ transplants continues to increase throughout the world, so too are the number of organ transplant recipients developing skin cancer.

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  • Did You Know...

    13 April, 2017 MasterControl

    That you can bring your team together in a virtual workspace for collaborative projects?

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  • Dietary Supplements Testing

    13 April, 2017 Sharon Phillips

    As noted in previous articles (see May 2008 issue of GXP LifeLine for example), the primary purpose of the final FDA Rule on Dietary Supplements (21 CFR Part 111) is to assure that current good manufacturing practices (cGMP) are followed and documented. The final FDA Rule on Dietary Supplements does not require manufacturers of dietary supplements to test their products before they are marketed.

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  • Effective Nonconformance Management Key to FDA and ISO Compliance

    13 April, 2017 Jason Clegg, Marketing Director, MasterControl, Inc.

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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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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  • 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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  • Blood Community Meets to Discuss Priorities

    13 April, 2017 MasterControl

    Clearly, there is no substitute for blood. There is no substitute for safety in handling blood, either. From donations at blood and tissue centers to transfusions in hospitals, the primary concern is for the purity of this life-giving fluid. The Food and Drug Administration (FDA) requires that blood establishments face some of the toughest regulations and standards today to ensure the safety of the blood supply.

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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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  • 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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  • 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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  • Automating Document Control Processes to Comply with FDA and ISO Requirements

    13 April, 2017 Jason Clegg, Marketing Director, MasterControl, Inc.

    The purpose of document control systems is to ensure that manufacturers build products that are safe and reliable. ISO and FDA Current Good Manufacturing Practices (CGMPs) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system.

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  • 21 CFR Part 601 and Vaccine Approval

    13 April, 2017 MasterControl

    21 CFR Part 601 and Accelerated Vaccine Approval: Five Things You Need to Know21 CFR Part 601 Provides Basis for Accelerated Vaccine Approval

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  • U.S. Biovigilance Network: Hemovigilance System

    13 April, 2017 Barbee Whitaker, Ph.D. AABB, Director, Data and Special Programs

    AABB, formerly the American Association of Blood Banks, and the Department of Health and Human Services have partnered to develop the U.S. Biovigilance Network. This network will, for the first time on a nationwide basis, collect and analyze data to identify trends and recommend best practices to reduce adverse reactions and incidents associated with blood transfusion and related biological therapies. Ultimately, the analyses of this data will enhance patient safety, make better use of blood and

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  • Blood & Biologics Article - Preparing For EU Assessment

    13 April, 2017 MasterControl

    By Becky SeeDiscusses how a U.S. blood center should prepare for an EU inspection.A safe and adequate blood supply is essential to the practice of modern medicine. New advances, particularly in the area of automation, have enhanced both safety and blood availability on an international scale.  Sovereign countries formerly looked to their own citizens for their blood plasma needs; today, plasma is an international commodity and as such, its collection centers are assessed by European a

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  • Tracking Blood Electronically Article

    13 April, 2017 Jerry D. Holcombe

    Blood centers have been using reliable and easy-to-scan barcodes to positively identify and track blood products for decades. Radio Frequency Identification (RFID) technology has been widely used in other industries with myriad applications for years. Marrying the two technologies for transfusion medicine can make it possible to "read" containers of blood simultaneously, reduce costs, streamline operations, and ultimately prevent mismatched blood at the point of transfusion. The addition of RFID

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  • Conferees Seek Paths to Improving Blood Center IT Systems

    13 April, 2017 MasterControl

    Blood community professionals and vendors met with officials from the Food and Drug Administration in a first-of-its-kind conference examining the impact of federal regulations on the development of donor and transfusion information technology (IT) systems.

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  • Blood Substitute's Effectiveness and Safety Addressed In Large Clinical Trial

    13 April, 2017 MasterControl

    A predicted shortfall of over 4 million units of blood worldwide is driving the need to develop an alternative to red blood cells.Academic and industry researchers participated in a Phase III multi-center clinical trial and found that use of a blood substitute was relatively safe in patients under 80 years old who have a moderate need for transfusion, up to the equivalent of three units of regular blood.Published in the June edition of the Journal of Trauma® this study is the first

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  • The Changing Face of Biobanks

    13 April, 2017 Jeanene Swanson

    Biobanking is changing rapidly, and it's in no small part due to the demands of systems biology. While small, university-centered banks have existed for decades, large-scale biobanks - whether tissue repositories or population databases - have recently been implemented all across the world. Many are also adding clinical annotation, genetic data, and increasingly genomic, proteomic, and other 'omics information. Population-wide biobanks exist in Iceland, the UK, Sweden, Canada, Estonia, Latvia, S

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