• 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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  • 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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  • 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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  • 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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  • New Report Highlights Need to Reduce R&D Cost

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

    Most pharmaceutical and biotechnology companies already feel the pressure to reduce their R&D costs. A recent report showing a decline in the ROI for R&D among some of the world's biggest companies is not going to ease the pressure.

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  • The EMA 2012 Guidance for Process Validation

    19 February, 2013 Peter H. Calcott, Ph.D., President, Calcott Consulting LLC

    In February 2012, the Committee for Proprietary Medicinal Products (CPMP) issued the latest version of the new EU Guidance for Process Validation (PV). At the end of October, the opportunity for consultation (comments period) closed, marking the time when the various committees review the comments for inclusion or modification of the document. Sometime in 2013, the formalized document will be issued for use. However, generally, what is presented at this stage is often close to the final versio

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  • Transitioning from an FMEA Risk Analysis to a Total Risk Management System

    31 January, 2013 Richard Vincins, Vice President, Quality Assurance Consulting, Emergo Group

    Traditionally companies have been performing risk analysis to identify hazards, categorize the risk, and find methods for mitigating those risks. This approach has only been focused on the finished product with a limited view during design controls, not on how product is actually used. The risk analysis has been done as part of design and development with the development team themselves identifying the risks and hazards. What we are seeing over the last few years is that risk analysis or risk

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  • Quality Professionals: How to Increase Your Job Security

    31 January, 2013 Cindy Fazzi, Staff Writer

    The life science industry has not been immune to the global economic downturn, with pharmaceutical companies such as AstraZeneca, Roche, and AMAG Pharmaceuticals recently announcing layoffs. Similarly, medical device companies such as Stryker, Medtronic, and Smith & Nephew have announced job cuts. So, is there such a thing as job security anymore?

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  • 100% Training Complete ≠ 100% Effectively Trained

    31 January, 2013 Vivian Bringslimark, President HPIS Consulting, Inc.

    "Can you run me a training report? I need to know where we stand with our training effectiveness program!" For a training manager, this is a double-edged sword. While it is very encouraging that upper management is taking an interest in the training program, focusing merely on the percentage of completion does not measure training effectiveness.

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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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  • 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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  • 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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  • Highlights of the 2012 Revised EU Pharmacovigialnce Regulations

    29 January, 2013 Sidney N. Kahn, Pharmacovigilance & Risk Management, Inc.

    In December 2010, the European Commission (EC) published legislation for implementation in July 2012 that made the most sweeping changes to European pharmacovigilance since 1995. Directive 2001/83/EC, covering non-centrally approved products, was amended by 2010/84/EU, and Regulation EC/726/2004, governing centrally approved products and European Medicines Agency activities, was amended by 1235/2010. The goals of the new requirements are to:

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  • Developing a QMS: Should You Buy or Build?

    11 December, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems.

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  • Peeling the Onion to Improve Human Reliability

    11 December, 2012 Stacy Berkshire, Senior Director of Global Quality Programs, Perrigo Company

    Humans will make mistakes. Industries have been focusing on strategies to reduce or even eliminate human error in efforts to keep consumers and employees safe. Pharmaceutical companies are responsible for ensuring that their products are safe, labeled correctly, have the correct strength, are pure, and are produced with good quality. In the pharmaceutical industry when deviations are identified as a result of an error, organizations follow a deviation investigation process to understand the root cause and put in a corrective action to fix the problem.

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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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  • 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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  • FDA User Fees: What Have They Done for You Lately?

    28 November, 2012 Marla Scarola, M.S., RAC, Senior Consultant, The Weinberg Group Inc.

    The U.S. Food and Drug Administration (FDA) user fees have been a fact of life for regulated industry for nearly two decades. Over the past 20 years, the Prescription Drug User Fee Act (PDUFA) has allowed FDA to speed up review times for new drug applications (NDAs) and biologic license applications (BLAs), ultimately decreasing the amount of time it takes drugs and biologics to reach the market.

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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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  • 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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