• 5 Tips for Winning Executive Buy-In for a New QMS

    26 May, 2015 Matthew M. Lowe, Executive Vice President, MasterControl Inc.

    If you’re facing executive or organizational resistance to your plan to automate your quality system, you’re not alone. There are many quality and IT professionals who are in the same boat. They have the toughest time convincing senior management not just about the merits of an electronic quality management system (EQMS) but about the real value of quality.

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  • Change in Pharmaceutical Manufacture

    28 May, 2015 Peter Murray, Consultant

    Within the pharmaceutical industry, the concepts of validation, change, change control, deviation and out of specification (OOS) are often treated as distinct activities which operate with a significant degree of independence.

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  • CAPA and Root Cause Analysis for the Food Industry

    2 June, 2015 Dr. Bob Strong, SAI Global Assurance Services

    A thorough and effective CAPA can provide many benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections.

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  • Don’t Call Me Jim Cramer but Here are My Top 5 Pharma Trends

    3 June, 2015 Lane Hirning, Product Management Director, MasterControl Inc.

    Judging by a recent report forecasting future growth, the pharmaceutical industry is thriving despite the recent economic downturn. A market research firm is estimating a 30 percent increase in global medicine spending by 2018, which is great news for the industry (1). The same report cited the anticipated launch of 200 new revenue-boosting drugs within the next five years.

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  • EU vs US: What are the New Track and Trace Requirements?

    4 June, 2015 Wolfgang Schmitt, Director Operations, CONCEPT HEIDELBERG GmbH

    In 2011, the European Commission published Directive 2011/62/EC, the so-called Falsified Medicines Directive (or FMD).One goal was the fight against counterfeit medicines through serialization and verification. In 2014 the technical characteristics of these key ideas were defined, the unique identifier (UI), delivering the possibility of verification of the authenticity of single folding boxes. The unique identifier contains information on the:

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  • Tales from the Front

    9 June, 2015 Morris Sherwood Director, Regulatory Affairs and Quality Assurance Isolite Systems

    So far in my 26 years of working in medical devices I have had many an adventure when it comes to FDA and Notified Body Inspections. I love inspections. I know it sounds crazy but there is this Zen place you get to during an inspection. You must practice patience. You must not think you know exactly what your inspector is thinking. At the same time, it is this amazing game of psychological chess whereby you watch your opponent’s moves and think five moves ahead, only to have your strategy thrown out the window when the inspection zigs rather than zags.

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  • FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users

    11 June, 2015 Stacie L. Ropka and Chad A. Landmon Axinn, Veltrop & Harkrider LLP

    What does the Food and Drug Administration (FDA) consider to be “minimal manipulation” and how are human cells, tissues and tissue-based products (HCT/Ps) made from adipose tissue regulated by FDA? These questions were addressed in two draft guidances issued by FDA in late December of 2014. The first, Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations (1), focuses on how adipose tissue is defined and thus how adipose-based HCT/Ps are regulated by FDA. The second, Minimal Manipulation of Human Cells, Tissues and Tissue-Based Products (2), focuses on the types of cell and tissue processing that would be considered more than minimal manipulation, resulting in the regulation of the cell or tissue-based product as a drug, biologic or medical device. Although they are not yet final, these guidances shed light on FDA’s current thinking and may signal that FDA will make it more difficult for products to be regulated solely under Section 361. Not only will such a position by FDA impact development of new HCT/Ps, but it could threaten the regulation status of currently marketed HCT/Ps.

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  • 7 Ways to Reduce Human Error on the Drug and Device Manufacturing Floors

    18 May, 2018 Ginette Colazzo, President, Ginette M. Collazo Human Reliability Consultancy

    As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of failures and defects. Sadly, little is known about the nature of these events mainly because the quest for answers ends where human error investigations should begin. This situation has become very evident to regulators and GMP enforcement agencies are being more critical of the approach, result, and effectiveness of corrective and preventive actions or CAPAs when dealing with human performance issues. In order to successfully achieve this goal, we have to understand how to improve the way we deal with these types of situations.

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  • How 3-D Printing is Revolutionizing Medical Devices

    18 June, 2015 Lisa Weeks, Marketing Communications, MasterControl

    Imagine a time when a clinician can modify and manufacture an implant sized for a particular patient on-demand in a health care facility—or print a human organ as easily as a paper document. As futuristic as it sounds, that time is not far off, according to scientists who continue to find new and truly mind-blowing ways to apply three-dimensional (3-D) printing techniques to the medical field.

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  • Study: Doctors are Ready to Embrace mHealth Tools

    23 June, 2015 Lisa Weeks, Marketing Communications Specialist, MasterControl

    Mobile health, or mHealth, has gained significant momentum over the past couple of years, and it will continue to influence product development in 2015. Millennials raised on technology are providing device makers with the unprecedented opportunity to sell directly to consumers in the form of wearable devices and mobile health applications that allow patients and physicians to interact clinically from different locations. The popularity of mHealth tools has been fueled by the growth of the smartphone industry.

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  • Device Makers Urged to Ramp Up Their Security Efforts

    30 June, 2015 Lisa Weeks, Marketing Communications Specialist, MasterControl

    The Anthem data breach should be a wake-up call to the health care industry, according to security experts. On February 5, 2015, hackers stole the social security numbers and personal information of 80 million Anthem members and employees, leaving them vulnerable to identity theft and blackmail.1 While the insurer may be one of the biggest health care companies to suffer a breach, it certainly isn't the first.

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  • From Open Payments to OpenFDA, the Push for Global Transparency is Accelerating

    7 July, 2015 Lisa Weeks, Marketing Communications Specialist, MasterControl

    Transparency has been a hot topic in life science circles in recent years. So hot, in fact, that it has almost become a buzzword, which implies that it lacks real substance or staying power. Transparency advocates, who are pushing to make health industry data—everything from clinical trial results to procedure pricing information—more accessible, would disagree.

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  • It’s Hot in Here—Quality, Compliance, and Romance

    8 July, 2015 Cindy Fazzi, Editor, MasterControl Insider

    Sun, spice, and romance—they’re everything I associate with summer. And I’m not talking about your love life, but your quality system. Indulge me for a moment and let me talk about the two things—quality software and romance—that preoccupy me most. I’m a full-time marketing writer and a newly published romance author. By day, I write about quality and compliance. By night, I write about people who live happily ever after (known as HEA to romance readers).

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  • Ensuring Proper Training for Clinical Research Staff in Less Time

    9 July, 2015 Sandra Maddock, President & CEO, IMARC Research

    There has never been a more exciting time to be involved in clinical research. We’re seeing more advances in life-changing medical devices and pharmaceuticals than at any other time in history, creating a growing demand for qualified clinical research associates.

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  • eMDR Compliance Deadline Looms: Last Minute Tips for Procrastinators

    15 July, 2015 Alex Butler, Product Manager Life Science Applications (LS APPs), MasterControl

    In February of 2014, the FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit initial and supplemental MDRs in an electronic format via the Electronic Submissions Gateway (ESG), rather than in paper form through Form FDA 3500A. The compliance deadline of August 14, 2015, is fast approaching! Will you be ready?

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  • Don't Just Fix It: Find It Before Your Customer Does

    14 July, 2015 Anna Thornton, Analytics Operations Engineering

    It is human nature to find a single cause of a problem, fix it, and assume everything is fine. In fact, the use of a scapegoat is documented in writings from four thousand years ago. All of the sins of a community were laid on the head of a single goat that was then driven into the wilderness, relieving every one of their problems. Four millennia later, we still believe in the power of the scapegoat to take away problems. When a product fails in the hands of the customer, triggering a recall or creating excessive warranty costs, companies quickly find a solution (or fire someone) and assume all is well.

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  • 4 Reasons Why Document Review is Crucial to Compliance

    25 June, 2015 Cindy Fazzi Editor, MasterControl Insider

    When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

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  • Get Products to Market Sooner by Systematizing Quality Cycles

    16 July, 2015 by James Jardine, Marketing Communications, MasterControl

    It all starts with an initial idea developed with a collaborative team. Input is gathered from all the necessary sources and then tweaks to the original concept are made as needed. Many different types of reviews, approvals, and regulatory checks are also required during this development stage. Then it’s time to provide suppliers or vendors with specific orders to ensure all the puzzle pieces will fit together as planned. Once your organization’s employees receive all the training they need to make the product according to the specifications that have been devised it feels like you’ve almost reached the finish line. Now you just flip a switch and watch as the magic is made while you celebrate your magnificent accomplishment, right?

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  • Why Do You Do What You Do?

    31 March, 2015 Jon Beckstrand CEO, MasterControl Inc.

    Have you ever asked yourself why you do what you do? When you find yourself buried in quality procedures and SOPs, or embroiled in a heated meeting over incomplete CAPA tasks, do you ever question the meaning of your work?

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  • European Supply Chain: A Series of New Regulations in Force

    21 July, 2015 Wolfgang Schmitt, Director Operations, CONCEPT HEIDELBERG GmbH

    The new EU Directive 2011/62/EU and its delegated acts keep on changing the pharmaceutical supply chain. The directive introduced numerous Delegated Acts with different time schedules and had some impact on revisions of several chapters of the EU-GMP Guidelines.

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