Showing items tagged as Regulations

  • Three Common Reasons Biologics Companies Receive FDA Form 483 Notices

    21 December, 2017 by Marci Crane, Staff Writer, MasterControl

    Biologics companies that wish to sell product in the United States should be ready at all times for a Food & Drug Administration (FDA) inspection. FDA inspectors have the authority to issue a Form 483 notice, which is a documented form that communicates when a company’s practices are not in compliance with regulatory standards.

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  • Canada’s Evolving Regulatory Landscape

    26 September, 2017 Raleigh Malik, PhD, Sr. Scientist, DIA

    Canada’s sesquicentennial marks a period of advancement and newfound transparency, where the past has set the stage for innovators to generate novel, yet safe and effective, health care products for Canadians. From the discovery of insulin at the University of Toronto in 1921 to the development of the first HIV preventative vaccine in 2013 (which is currently undergoing Phase II trials), Canada has a rich history of drug innovation. However, with health care product innovation comes government oversight and regulations required to ensure safe and effective treatments for the public.

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  • 6 Steps to Simplify Software Validation

    10 September, 2015 Kevin Ballard, Director of Software Validation, MasterControl

    Validation is one of the most time-consuming and resource-intensive activities when implementing eQMS software in a regulated environment, often delaying implementation and an organization’s ability to go live with new software.

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  • Cut through the Clutter: Simplifying Regulatory Compliance

    29 April, 2015 David R. Butcher, Marketing Communications, MasterControl

    For any business, the process of getting a product to market – from concept initiation through release – is often long and arduous. For manufacturers that must navigate the maze of regulatory red tape, hoops and hurdles, the process of bringing an innovative product to market can be even more punishing and the stakes even higher: one wrong step can stall or completely derail the entire product development effort, giving competitors a major advantage in the race to market. race to market.

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  • 5 Practices for Managing Change When ISO 9001: 2015 Arrives

    14 April, 2015 Terrance Holbrook, Senior Product Manager, MasterControl

    Quality management system (QMS) standard ISO 9001:2008 is about to undergo some significant changes soon, with the new ISO 9001:2015 due to be published later this year. As a result of proposed fundamental changes to the structure and contents of the standard, this revision will be important to organizations with, or seeking, ISO 9001 certification and those implementing ISO 9001 systems.

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