• Five Steps to Building Process Efficiency with Your Supplier

    20 January, 2015 Stephen Gerald O’Neil, Consultant

    In order to achieve success with your outsourced manufactured medical devices, there must be cohesiveness between the manufacturer (Supplier) and the product developer (Customer). I’ve exemplified this role as that of the supply chain liaison consultant, involved directly with the development of the manufacturing processes, while in step with the roll-out of the product design intent. This article will discuss the five steps required to accomplish all of this while defining the role of the consultant. The consultant provides the tools and leadership to maximize the value of the supplier in their partnership with the customer.

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  • Getting Ready for ISO 13485:201X (Part 1)

    22 January, 2015 Lisa Weeks, Marketing Communications

    As most of you know, ISO 13485–Quality Management Systems—Requirements for Regulatory Purposes is being revised. ISO 13485:201X, as the final revision is being referred to, is expected to be available in late 2015 or early 2016. Understandably, this is causing anxiety for medical device manufacturers, many of whom are still struggling to conform to the current version of the standard. With this in mind, let’s review the basics of the ISO: 13485. In future posts, we’ll examine why the standard is being updated, and the most significant changes you can expect to see.

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  • Med Device Excise Tax Debate: Let Your Voice Be Heard

    27 January, 2015 Matthew M. Lowe, Executive Vice President, MasterControl Inc.

    Since January 2013, medical device manufacturers and importers have been paying a 2.3 percent excise tax as part of the Affordable Care Act. The tax is assessed regardless of the company’s profitability.

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  • Risk Management in Clinical Research: Process and Application

    29 January, 2015 Emily Haglund, Clinical Auditor, IMARC Research Inc.

    Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding risk based approaches to clinical research. These documents include FDA’s “

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  • Measuring Risk Management Outcomes

    3 February, 2015 Rod Farrar Director, Paladin Risk Management Services

    In his book Decision Making: Risk Management, Systems Thinking and Situation Awareness, Dr Alan McLucas introduces the concept of the Risk Management Paradox: “The task of managing risks effectively is confounded by a classical paradox. That is, if risks are being effectively managed as a matter of routine, there will be very few surprises. Nobody becomes aware of just how effective careful risk-management actions have proven to be. Nobody slaps the manager on the back and congratulates them for a job exceedingly well done. In stark contrast, however, if risks are managed poorly, the whole world lines up to say so.”

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  • Murray Explains ISO 9001 Update at MD&M West

    4 February, 2015 Robyn Barnes, Marketing Communications, MasterControl

    Murray is a frequent MD&M West speaker who is a recognized authority on ISO 9001.  He's authoritative and entertaining, so this is a session you won't want to miss.

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  • CAPA Should Not Be a Dreaded Four-Letter Word

    5 February, 2015 Cindy Fazzi, Editor, MasterControl Insider

    In a regulated environment, CAPA is a requirement for addressing and mitigating deviations and nonconformances. A quick review of FDA warning letters indicates it’s a dreaded four-letter word for many companies cited for violations.

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  • FDA Audit Practices: the 10 Most Commonly Cited Drug GMP Deficiencies of 2012-2013

    10 February, 2015 Ken Christie COO, VTS Consultants, Inc.

    If there is one word within the life science industries that causes concern and anguish it is “audit.” As with any evaluation process, the success of getting through a regulatory audit is a combination of preparedness with regards to what to expect, knowing the current regulations that apply to your product and knowing what tends to be the areas of deficiencies in audits performed. All of these items can be researched on the web and the time and effort to review and provide training on them will serve companies well.

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  • Success By the Numbers (or Why Being Science-y is a Good Thing)

    12 February, 2015 Craig Gygi, Executive Vice President, Operations MasterControl

    How do you know if you know? In other words, how do you know when you have sufficient knowledge to reliably manage or improve a process? This last question reveals the foundation of all quality, regulatory, and compliance work.

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  • The Perks of Pursuing a Career in Quality Management

    17 February, 2015 Greg Peckford, Founder, Quality Career Advancement

    It is a bit of a mystery to me that more is not made of the personal career advantages and knowledge gained from performing procedural assessments, audits and other quality management related functions. For me personally, this type of activity has been one of the key factors in my career progression and advancement.

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  • Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises

    18 February, 2015 Suzanne M. O'Shea, Counsel, Faegre Baker Daniels LLP

    Two years ago, in January 2013, FDA published the final regulations on Good Manufacturing Practices for Combination Products.[1] These regulations are built on the concept that the constituent parts of a combination product retain their regulatory identity as a drug, device, or biological product, even after they are physically, chemically, or otherwise combined into a single-entity combination product (i.e., prefilled injector or drug eluting stent) or co-packaged together.[2] Therefore, all the good manufacturing requirements associated with each constituent part must be complied with in the manufacture of single-entity and co-packaged combination products.

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  • 6 Ways to Ensure Your QMS Meets FDA and ISO Compliance

    19 February, 2015 David R. Butcher, Marketing Communications, MasterControl

    An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.

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  • FDA Issues New Draft Documents Related to Compounding of Human Drugs

    23 February, 2015 MasterControl

    The U.S. Food and Drug Administration has issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.

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  • 7 Document Management Blunders that Jeopardize Compliance

    25 February, 2015 James Jardine, Marketing Communications, MasterControl

    Achieving regulatory compliance without any document management slipups is like walking through a dog park without getting your shoes messy. It seems nearly impossible to find a safe route to your compliance destination and there are countless potential mistakes you can make at any step along the way. Since the path to compliance is narrow and treacherous, here are seven examples of common document management mistakes that can jeopardize your compliance and a few ideas on handling these types of problems.

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  • Four Reasons to Automate SOP Management in FDA and ISO Environments

    26 February, 2015 David R. Butcher, Marketing Communications, MasterControl

    To maximize efficiency and safety, successful companies across all industries employ effective standard operating procedures (SOPs). For companies doing business in regulatory environments, effective SOP management is imperative. An electronic SOP management system can dramatically improve SOP management in at least four key areas.

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  • After Five Years, Compliance-First Approach is Still Obstacle to Improving Product Quality

    3 March, 2015 Dan Matlis, Founder and President, Axendia

    Five years ago we looked at the road blocks to improving product quality.  In the intervening years there has been little change by most Med-Tech Companies.  The matter of Product Quality vs. Compliance recently has been given a push toward the Quality side by efforts made by the FDA.  The four-part whitepaper reveals how aligning process improvement initiatives with technology platforms and an integrated approached to product quality can help Med-Tech organizations improve produc

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  • FDA Launches Drug Shortages Mobile App

    4 March, 2015 Christopher Kelly, FDA CDER Trade Press

    Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.

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  • 3 Levels of SQF Certification

    5 March, 2015 Sam Lewis Associate Editor, Food Online

    SQF Certification is an assurance, assessment, and audit program that can increase your company’s marketability, domestically and globally.

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  • Data Integrity Starts With User Access

    10 March, 2015 Jamie Colgin, Colgin Consulting

    In my next few blog posts, we'll be covering user access and how it can impact data integrity. For starters, let's explore the Principle of Least Privilege. What is it?  What happens when it's violated? Finally we'll map out five actions you can take to protect your company.

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  • The Journey to Supply Chain Excellence

    12 March, 2015 Ed Rausch, VP of Global Marketing, Elemica

    Some goals haven’t changed. Businesses in 2015 still have the common pursuit of growing revenues, profits, and market space, and leading companies are relying on building collaborative relationships in their extended supply chains to meet these goals in a responsible and sustainable way. Building powerful and more intimate relationships, extending across a critical mass of trading partners, leads to continuous improvements in company performance, agility, and differentiation.

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