• FDASIA: Key Statutory Changes for Medical Device Companies

    29 January, 2013 Pamela F. Forrest, Elaine H. Tseng and Steven Niedelman, King & Spaldings FDA/Life Sciences Practice Group

    The Food and Drug Administration Safety and Innovation Act (FDASIA), enacted July 9, 2012, is the most recent statute impacting FDA's regulation of medical devices. FDASIA is significant not only because it reauthorizes user fees for device submissions, in exchange for FDA's commitment to achieve certain performance goals in the review of those submissions, but also because it institutes various other changes to the device regulatory framework. Several of these should or may benefit medical d

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  • FDA Says Part 11 Guidance Remains Status Quo

    4 May, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    Time and again, rumors surface about the possible update of the 2003 guidance on the scope and application of 21 CFR Part 11. The never-ending speculation attests to the enduring interest in Part 11, not to mention the continued scrutiny of the regulation.

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  • FDA Issues Draft Guidance on Biosimilar Product Development

    22 March, 2012 PharmaManufacturing.com

    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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  • FDA Fields Tough Questions About Inspections

    30 August, 2012 Agnes Shanley, Editor in Chief, PharmaManufacturing.com

    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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  • FDA Compliance Officer: Industry, FDA Must Focus on Device Quality (Not Just Compliance)

    28 November, 2012 Arundhati Parmar, www.medcitynews.com

    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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  • Is FDA to Blame for Biomedical Industry's Slow Growth

    31 January, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    Given the global economic challenges today, it is understandable that the biomedical industry sees lack of funding as a key obstacle in growth. What is surprising is that the industry also sees the FDA and the current regulatory environment as a stumbling block.

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  • FDA Compliance Software

    18 April, 2017 MasterControl

    Companies competing within the rigorous FDA regulated environments know how important attaining and sustaining compliance is to yearly success which can be easily achieved through MasterControl's FDA compliance software. MasterControl Inc. is a leading provider of FDA compliance software, helping hundreds of life science companies around the world realizes their EU regulatory and FDA compliance goals. Our quality management system meets all FDA 21 CFR Part 11 regulations.

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  • Creating, Staffing and Managing an Inspection War Room

    4 May, 2013 Walt Murray, Director of Quality and Compliance Services, MasterControl Inc.

    When I served in the military there was a term used that is still pretty familiar today: "sound general quarters!" When this order was issued, everyone instinctively stopped what they were doing and manned whatever station was theirs during that time. All commands during general quarters came from the war room behind the bridge of the vessel.

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  • Challenges in Combination Product Regulation

    17 July, 2012 Mark D. Kramer, President, Regulatory Strategies, Inc.

    Combination products raise a variety of regulatory challenges. In addition to the unique technological and scientific challenges these products may raise, when drugs and devices, drugs and biologics or devices and biologics are combined to create a new product, consideration must be given to what regulatory requirements will apply to the combination product as a whole. This article explains the key principles and processes established for the assignment, premarket review, and postmarket regula

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  • Ten Points for Successfully Addressing Warning Letters

    10 July, 2013 By Maria Fagan, President, Regulatory & Quality Solutions LLC

    Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies responding well to the FDA’s demand for prompt compliance will ultimately return to the agency’s good graces and through the experience develop processes that result in better business, both culturally and financially. But getting to that point may be a slippery slope if the issues in the letter are not

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  • What SOPs Do You Need As A Dietary Supplement Distributor?

    31 January, 2013 Laurie Meehan, Internal Project Manager, and Rosanne Sylvia-Heeter, Director of Good Manufacturing Practice Compliance, Polaris Compliance Consultants

    If you look at the cGMP regulations for dietary supplements, you'll notice that only one subpart includes the words "holding" or "distributing" in its title. With only 10 or so individual requirements, the aptly-named Subpart M, "Holding and Distributing," is shorter than most. If you're thinking this means there's a much lighter regulatory burden placed on companies that simply hold or distribute dietary supplements than on companies that manufacture them, you'd be right. At the same time, y

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  • Contract Management: What's Compliance Got to Do with it?

    30 August, 2012 Cindy Fazzi, Staff Writer

    Contracts are typically the purview of the finance and legal departments. But in regulated environments, the regulatory, quality, and other departments might also be involved in the contract management process.

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  • Is Quality by Design just for Big Pharma?

    5 June, 2012 Peter H. Calcott, Ph.D., President, Calcott Consulting LLC & Senior Consultant, NSF-DBA LLC

    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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  • MasterControl Presents 'Change Control, a Risk-Based Approach' at MD&M Texas

    31 January, 2012 MasterControl

    MasterControl Inc. will present "Change Control--a Risk-Based Approach" as a workshop at the MD&M Texas 2012 Conference, March 15, 2012, at the Fort Worth Convention Center in Fort Worth, Texas. MasterControl's Kevin Marcus, product manager and medical device expert, and Walt Murray, director of quality and compliance services, will conduct the workshop.

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  • Five CAPA Tips that Help Ensure Compliance

    24 April, 2013 MasterControl

    Having been intimately involved in how the U.S. Food and Drug Administration ("FDA") inspects current Good Manufacturing Practice ("cGMP") requirements for nearly two decades, I find myself repeating certain things to companies. Most often, the issues I repeat relate to Corrective and Preventive Action ("CAPA") systems. CAPA systems are a focal point in FDA inspections precisely because they are the process that manufacturers follow in case something goes wrong. In the same way that a person'

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  • Corrective Action and Preventive Action: What's the Difference?

    30 October, 2012 MasterControl

    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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  • Correcting and Detecting CAPA Horrors

    24 April, 2013 MasterControl

    The long history of Corrective and Preventive Action (CAPA) requirements within the Food and Drug Administration's (FDA) Quality System Regulations---and specifically 21 CRF 820.100 and ICH Q10---implies that most biomedical companies have evolved a certain level of mature thinking and a good understanding of the fundamental requirements for CAPA systems. This, unfortunately, is not always the case. I am currently spending a lot of time working with client companies in remediation mode; that is,

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  • Surviving the Hosted Compliance Audit: Front Line, Back Room and in the Shop

    30 March, 2012 MasterControl

    Compliance audits present their own orientation to an organization that wants to present the perfect front while being asked to air their dirty laundry. Is this inspection about smoke and mirrors or does the audited facility present a "zipped-tight" posture toward the investigator?

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  • Remote Audit: Out of Sight but Not Out of Mind

    31 January, 2013 by David Ade, Customer Success and Reference Manager, MasterControl, Inc.

    In life science and other regulated environments, audit is necessary to comply with regulations and to ensure the quality of products. Regulated companies recognize not only the importance of audit, but the value of frequent audits. However, in these economically challenging times, frequent on-site audits can be costly.

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  • Building a Quality Plan for Implementing EN ISO 14971:2012

    14 August, 2013 Robert Packard, Regulatory Consultant, MedicalDeviceAcademy.com

    On May 16 of 2012, the European Committee for Standardization (CEN) approved a revised European National Standard for medical device risk management: EN ISO 14971:2012. There were no changes to the main body of the Standard (i.e. – Clauses 1 through 9). Instead, the revised European National (EN) version identifies seven deviations in Annex ZA, ZB, and ZC with respect to the intent of the MDD, the AIMD, and IVDD respectively. Those seven deviations are:

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