• 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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  • Single Sourcing of Critical Components: Strategies for Optimization

    28 November, 2012 Peter Knauer, Partner Consultant, MasterControl Quality and Compliance Advisory Services

    The increase in virtual or under-resourced biomedical companies has resulted in a dramatic shift in outsourcing components and supplies. Larger companies are also joining this outsourcing trend. Even more profound is the increasing reliance on single-sourced suppliers, particularly for critical components. While this can be an effective way to reduce the cost of goods and improve efficiencies, there are some significant risks associated with this practice. This article examines these risks and a

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  • Can You Use Automated Testing Tools as an FDA-Regulated Company?

    30 October, 2012 Janis Olson, Vice President of Quality and Regulatory Services, EduQuest, Inc.

    Can you use automated testing tools as an FDA-regulated company?

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  • Why You Need to Go Beyond Risk Analysis

    30 October, 2012 Richard Vincins, Vice President of Quality Assurance, 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 itself identifying the risks and hazards. What we are seeing over the last few years is that risk analysis or risk ass

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  • How to Build a Strong Supply Chain Team

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

    In today's fiercely competitive global market, finding good suppliers that help create efficiencies, reduce cost, and support compliance efforts is critical to the success of manufacturers in regulated environments. Let's say you have found excellent suppliers, the question is: How do you maintain control over your suppliers and also keep good relations with them?

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  • Quantifying Quality for GxP Compliance

    30 October, 2012 Emma Barsky and Len Grunbaum, Regulatory Compliance and Operational Consultants

    GxP professionals understand the need for quality and quality systems and we discuss quality with one another on a daily basis. But how do we measure it? How do we quantify our results? Once again we turn to Len Grunbaum and Emma Barsky, regular contributors to GxP Perspectives, for their insights on how to quantify quality for the development, manufacture, and distribution of health products such as drugs, medical devices, and biologics.

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  • How to 'Sell' Quality

    30 October, 2012 Deborah Mackin, Performance Strategy Consultant, New Directions Consulting

    ASQ CEO Paul Borawski asked us to comment on the question, "How do you 'sell' quality to decision makers?" While everyone theoretically believes in the importance of quality, there are times when the demands of the customer cause the focus to shift to speed and cost. Probably many quality heads of departments have been asked to compromise quality requirements at some point to get product out the door.

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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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • When Good Teams Go Wrong

    17 July, 2012 by Ruth Dubinsky, MS, President, Clarity Consulting

    How's your team doing? Are you hitting your targets without leaving "dead bodies" in the wake? Do you sense trust, commitment, and accountability from your fellow team members?

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  • Regulations Vary Worldwide but Risk Management is Common Demoninator

    17 July, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    To compete in today's global market, regulated companies must comply with innumerable requirements, directives, and standards coming from regional, national, and international bodies. While these requirements vary based on industry and the regulatory body involved, they do have a common denominator—emphasis on risk management.

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  • Implementing a New System: Why Training Reinforcement is Critical

    17 July, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    It all sounds familiar: You attend a training course that you are excited about. You spend two or more days soaking up new information. You take notes diligently. Before you know it, the training is over. You go back to the office. And after a while, it happens: The new knowledge fades.

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