• 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • Six Costly Mistakes that Start-Up CEOs Should Avoid

    28 November, 2012 Greg Davis, Founder & CEO, MedCelerate

    Representing one-third of the global medical device market, the European Union provides a significant opportunity for start-up medical device companies. But, it can also present costly challenges for the unprepared. Following are a half-dozen cautions drawn from real-world experience that could help you avoid the most common commercial pitfalls.

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  • Annex 11 and 21 CFR Part 11: Comparisons for International Compliance

    31 January, 2012 Orlando Lopez, Independent Consultant

    The two essential resources available to regulated life-science professionals regarding the validation of computer systems are: the Food and Drug Administration's (FDA) rule on Electronic Records/Signatures (21 CFR Part 11 aka Part 11) and the European Medicine Agency's (EMEA) Guidelines to Good Manufacturing Practice (GMPs) - Annex 11, Computerized Systems (aka EU Annex 11).

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  • Annex 11: The EU's New Expectations for Regulated Computerized Systems

    10 April, 2012 Martin Browning, President and Co-Founder, EduQuest

    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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  • Final FDA Rule on Dietary Supplements (21 CFR Part 111) Guidance

    14 April, 2017 Sharon Phillips

    In June 2007, the U.S. Federal Drug Administration issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations.

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  • Making the Transition to an E-System

    14 April, 2017 Janet Gough, Course Director, Center for Professional Innovation and Education

    This is the first part of a two part article.

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  • Making the Transition to an E-System - Part II

    Janet Gough, Course Director, Center for Professional Innovation and Education

    This is the second part of a two part article. (See Part I)

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  • New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care

    14 April, 2017 Robyn Barnes

    HHS Secretary Mike Leavitt recently announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.

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  • Life Science Executives Facing Jail Time?

    14 April, 2017 Marci Crane

    As corporate corruption--with or without executive intent--increasingly comes to light within the life science sector the FDA is reciprocally given additional power to administrate punitive measures. The FDA's increased powers include the following:

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  • The Hot Potato of Responsibility - How to Manage Outsourcing and Not Get Burned

    14 April, 2017 Martin Browning, President, EduQuest, Inc., and former FDA Investigator/Special Assistant to the Commissioner of Regulatory Affairs

    Everything can be outsourced - except responsibility. That's a rule the U.S. FDA lives by, and one you should embed in your policies, SOPs, and corporate culture.

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  • Optimizing Your eCTD Submission: How to Achieve an Efficient and Timely Review - GxP Lifeline

    14 April, 2017 MasterControl

    Ginny Ventura of the FDA?s Review Technology Staff shares the top 12 mistakes in eCTD submissions she sees nearly every day

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  • Do's and Don'ts in Process Mapping for Life Science Companies

    14 April, 2017 John Gagliari

    The medical device and pharmaceutical industries are built upon process orientation to complete tasks in a uniform and documented fashion. Both industries also depend upon a systematic series of linked and reproducible activities completed by trained people to enable inputs to become outputs and outputs to realize a return on investment.So, how does process mapping help these industries in turning inputs into predictable outputs that would help them comply with regulations, as well as realize co

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