GxP Lifeline

 

  • AABB Abstract Submission: Everything You Wanted to Know but Didn't Ask

    MasterControl

    The AABB Annual Meeting and TXPO, slated for October 24 - 27 in New Orleans, hosts many educational activities. Among these is the Abstract Poster session, an opportunity to share your research with others and possibly obtain preliminary publication for grant and funding purposes.

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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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  • Biologic-Device Combination Products: Jurisdiction

    Joyce L. Frey-Vasconcells, Executive Director, PharmaNet Consulting, PharmaNet Development Group, Pharmanet.com

    More and more companies are developing combination products for many life-threatening and unmet medical needs. One area that holds much promise is the development of tissue engineered products which contain living cells or tissues combined with a device. As with any novel technology, questions regarding what the requirements will be by the regulators to obtain market approval is always an issue. This has been a changing dynamic in other parts of the world but the Food and Drug Administration

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  • Why Baldrige Works

    15 February, 2011 Rose Almon-Martin, V.P. Performance Excellence, MEDRAD, Warrendale, Pa.

    There's no doubt that the Baldrige Criteria drive excellent performance. Of course, the perennial question for any improvement approach is "What's the return on my investment?" Cargill, a $107 billion company that produces and markets food, agricultural, financial and industrial products and services, says Baldrige is a huge return on investment. Their divisions that use the Criteria achieve 130 percent of their earnings targets versus divisions not using the Criteria, who achieve about 82 perce

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  • Tips for Avoiding Internal and External Supplier Problems

    Seth Mailhot, Lead, FDA Practice, Nixon Peabody LLP

    The signing of the historic healthcare reform legislation will have a significant impact on both the medical device and pharmaceutical industries. A significant increase in the number of individuals carrying health insurance will translate into a greater demand for medical devices and pharmaceuticals. While this will improve profitability for many companies, it will present challenges to manufacturing and quality managers tasked with finding ways to quickly increase production.

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  • Avoiding the CAPA Calamity

    9 February, 2017 Ken Peterson, Director Quality Services, MasterControl, Inc.

    Anyone working in quality management is familiar with references to "Death by CAPA" or "CAPA Kills." The industry is rife with similar catch phrases. The "truth" is they are not far from the "truth." When my friend from FDA originally coined the expression "death by CAPA," it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all tha

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

    Brian Curran, SVP, Stategic Marketing & Product Management, MasterControl, Inc.

    FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training. (21 CFR 211.25 and 820.25) These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of non-compliance and improve product quality. This article identifies the basis for the requirement and examines the associated challenges for meeting the requirement and the shortcomings that

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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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  • How Auditing Supports Supply Chain Management

    6 October, 2010 Dennis R. Arter, FASQ, CQA

    There are four parts of supply-chain management:

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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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  • 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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  • 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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  • 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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