• Finding Ways to Cope with New Medical Device Tax

    19 February, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    Medical device companies started paying a 2.3 percent excise tax this past January as part of the Affordable Care Act, also known as "Obamacare." The industry has opposed the tax, which is being assessed on total revenues, not profits. The Obama administration has said the excise tax will be offset by an increased number of insured people receiving treatments; it's something that remains to be seen.

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  • The US Medical Device Industry: Future Growth Sectors May be Different Than You Think

    10 August, 2013 Michelle Bonn, Owner & President, Expedient Trade LLC

    The medical industry is one of the most stable industries with respect to growth.  However, we are seeing interesting global trends that will impact the sustainability of medical device manufacturers and suppliers across the United States.

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  • Employing Audits for Improved Supplier Performance

    3 April, 2012 Bob Mehta, GMP ISO Expert Services

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

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  • eMDR Conversion and Implementation - Part II

    27 March, 2012 Eugene Reilly, FDA's Center for Devices and Radiological Health

    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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  • eMDR Conversion and Implementation - Part I

    29 February, 2012 Eugene Reilly, FDA's Center for Devices and Radiological Health

    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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  • How Life Science Companies Can Leverage Mobile Technology

    10 April, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    Mobile technology has come a long way. Smartphones and tablets are getting better, smaller, and less expensive. It is no wonder that almost everyone has one.

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  • Quality and Risk Management in Clinical Studies

    17 July, 2012 Patricia Santos-Serrao, Senior Product Manager, Life Sciences, MasterControl, Inc.

    With all that goes into a clinical trial, from documentation and procedures, to a variety of study support staff, managing risk may often be overlooked or merely addressed in a reactive way. However, in order to increase success in clinical trials, an organization must have an efficient risk management plan and be proactive and not simply reactive. In order to obtain a complete understanding of risk in a clinical trial, a risk assessment must be taken from various perspectives. Also, risk man

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  • Clinical Research: Common Challenges in Sponsor-CRO Relationship

    28 November, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    Outsourcing thrives in good times and bad. Life science companies rely on contract research organizations to complement in-house work in times of growth and expansion, but they also rely on CROs to reduce costs in times of financial downturn.

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  • How Social Media Is Advancing Healthcare

    24 April, 2013 Laurie Meehan, Internal Project Manager, Polaris Compliance Consultants, Inc.

    Facebook’s IPO last year received a lot of media attention. While the news was mostly financial, the huge sums of money being discussed were not the only numbers associated with the social networking site that can give pause. Facebook now boasts more than a staggering 1 billion users. To put that in perspective, that’if Facebook were a country, it would be the 3rd largest in the world. And while Facebook is the biggest, it’s not the only social networking giant. Depending what source you co

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  • The European Qualified Person - What's It All About?

    17 April, 2012 Wolfgang Schmitt, Director Operations, CONCEPT HEIDELBERG GmbH

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

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  • Business Benefits of Archiving

    30 March, 2013 Jim Cook, CEO, Arkivum

    The word “archive” is springing up all over the world of IT and data management. Why now, and what are the implications to an organization working within the highly regulated world of a GxP environment? This article sets out some of the key business drivers around long-term data storage, and offers some lifelines to IT professionals drowning under a deluge of data.

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  • One Year Later: The FSMA and the Food and Beverage Industry

    18 April, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    A year has passed since the Food Safety Modernization Act (FSMA) was signed into law. Some of the changes envisioned under the FSMA are already in place, such as the FDA's new mandatory food-recall authority and the authority to detain food products that the agency has reason to believe are adulterated or misbranded.

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  • FDA Sets New Priorities for Foods and Veterinary Medicine

    17 July, 2012 News Desk, Food Safety News

    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 U.S. Biosimilar Pathway Nearly Three Years Later

    11 December, 2012 Erika Lietzan and Laura Sim, Covington & Burling LLP

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

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  • Trends in Q1 Warning Letters

    30 October, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    If you work in the life science industry, it is always a good habit to periodically check the FDA's website for enforcement actions and warning letters. You can glean important insights from the mistakes and weaknesses of other companies in your industry, maybe even your competitors. You will see what the FDA is emphasizing in inspections, perhaps see some trends.

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  • Surviving the Back Room During an FDA Inspection

    17 July, 2012 Christine Park, Christine Park & Associates

    During one of my early inspection experiences with the FDA, I found myself working with a team that felt it didn't need a backroom setup to review documents prior to bringing them to the investigator. Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.

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  • Process Verification vs. Process Validation: What You Need to Know

    10 May, 2012 Andrew Snow, Momentum Solutions, LLC and Walt Murray, MasterControl, Inc.

    Note: The views expressed in this article are those of the authors and do not necessarily represent those of their respective employers, GxP Lifeline, its editor or MasterControl, Inc.

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  • What Does a New FDA Quality Office Mean?

    14 August, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    The news that the FDA is creating a new Office of Pharmaceutical Quality probably set off the alarm bell for the industry. Does a new quality office mean new requirements? It’s the first question that comes to mind.

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  • The Importance of Computer Systems I/Os Accuracy Checks

    5 June, 2012 Orlando Lopez, Independent Consultant

    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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