• Identifying and Preventing Common Data Integrity Issues

    20 September, 2016 Joanna Gallant, Owner/President, JGTA LLC

    Because of the multitude of problems being found in regulatory agency inspections, data integrity is a hot issue for regulators around the world today. Data integrity is critically important to regulators for a variety of reasons, including patient safety, process and product quality. The integrity and trustworthiness of the data provides a baseline for the regulators opinion of the personnel and the company as a whole.

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  • Preparing for the Impending Medical Device Regulation

    23 September, 2016 Linda Chatwin Esq, RACUL LLC, Senior Customer Solutions Consultant

    It’s coming – and at this point, nothing will stop it. The Medical Device Directive (MDD) is being recast to a regulation – the Medical Device Regulation (MDR). It has been over four years in the making and the EU countries have spent many hours (actually over four years) working to agree on its Consolidated Negotiated Text.

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  • Tweet This — If You Want to be Slapped with an FDA Warning Letter

    27 September, 2016 Lisa Weeks, Marketing Communications, MasterControl

    Is the FDA starting to get serious about how medical devices and prescription drugs are being marketed on social media? Many experts think so, citing Kim Kardashian’s highly publicized misleading endorsement of the morning-sickness medication Diclegis® as an example. The offending post, which appeared on the reality star’s personal Instagram page, earned drug maker Duchésnay a warning letter, demanding an immediate retraction. The post was promptly removed—after it had garnered 450,000 likes from Kardashian’s over 42 million followers.

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  • How to Use Postmarket Surveillance Data to Gain a Competitive Edge

    29 September, 2016 Lisa Weeks, Marketing Communications, MasterControl

    Medical device companies are required to conduct postmarket surveillance (PMS) on their devices to maintain high product quality and safety. However, few companies realize the true value of the digital feedback they receive. In this post, we will explore current best practices for collecting and interpreting postmarketing intelligence, and discuss how you can use the information you acquire to gain a competitive advantage.

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  • Ignoring This Overlooked Risk Management Metric Leads You Down The Path To The Dark Side

    13 October, 2016 by Ed Rusch, Vice President, Corporate Marketing, Elemica

    Hurricanes. Power outages. Socio - geopolitical upheavals. Train derailment. Road closures. Contamination in a supplier facility. Terrorism, cyber-attack, sabotage or industrial espionage. Labor unrest. Global pandemic. Fires, floods and natural disasters. These incidents are not a work of science fiction and the number of them that can negatively affect the supply chain are real and virtually limitless.

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  • Renowned Physician Patch Adams Urges Techies to Help Build an Ethical World

    18 October, 2016 Cindy Fazzi, Editor, MasterControl Insider

    Patch Adams, the physician famously played on the silver screen by Robin Williams, urged IT professionals to help build an ethical and nonviolent world during his keynote speech at the 2016 Masters Summit in Salt Lake City.

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  • 10 Tips for Enabling Better CRO-Sponsor Collaborations

    19 October, 2016 Craig Morgan, Head of Marketing goBalto, Inc.

    By 2020 72% of clinical trials are anticipated to be outsourced, up from just 23% in 2012. Sponsors are seeking cost reductions, access to specialized knowledge, and increased speed and agility. Meanwhile, CROs focus is on business goals related to economic outcomes for their owners, investors and shareholders. Each group is expecting deliverables and timelines to be met or exceeded for potentially different business reasons, leading to a traditional client/vendor-type relationship. Though alliances and partnerships are increasing, there continues to be a client/vendor mentality at the operational and management levels, which perpetuates a lack of trust and empowerment.

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  • 4 Quality Management Tips We Can Get From Time Travel Movies

    20 October, 2016 David Jensen, Marketing Communications MasterControl

    Ever wish you could have a do-over? Wouldn’t it be nice to be able to go back in time to change or undo some event? Or what about going to a future time? Nothing illegal, maybe just to avoid the lines and hassle of getting a ticket to the next episode of Star Wars.

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  • 5 Best Practices for Developing Products Within a Highly Regulated Environment

    25 October, 2016 Tom KraMer, President & CEO Kablooe Design

    Do you have a great idea for a new medical device?  It's not as easy to get a product to market as it used to be. Following these five design research steps may 

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  • Top 7 Takeaways from AdvaMed 2016

    26 October, 2016 Lisa Weeks, Marketing Communications Specialist MasterControl

    Last week, I attended AdvaMed 2016, the leading medtech conference in North America. This year’s conference was the biggest yet, with more than 2,650 medtech professionals descending on Minneapolis for three days (October 17-19) of educational sessions, lively panel discussions and inspiring patient stories. As the birthplace of the modern medical device, and home to nearly 1,000 health technology companies, Minneapolis was a suitable host location to celebrate the tenth anniversary of the confe

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  • Retraining and Refresher Training: Aren’t They One in the Same?

    2 November, 2016 Vivian Bringslimark, HPIS Consulting, Inc.

    Ask an operations manager and he’ll acknowledge that what it’s called is less important than getting the “assignment” done and entered into the LMS. He’s usually more concerned about the loss of productivity during the training than the effectiveness of the training at that time. It isn’t until later when the training may have to be delivered again (repeated), that the comment “training doesn’t really work” is heard.

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  • How Frances O. Kelsey Blazed a Trail for Women in Regulatory Compliance

    3 November, 2016 Jon Beckstrand, CEO, MasterControl Inc.

    Whether it’s the ibuprofen we take to remedy a headache or the world’s smallest pacemaker approved by the FDA earlier this year, we can rest assured that these medical products passed scientific scrutiny and complied with stringent regulations. We can thank a woman who blazed a trail at the FDA—Frances Oldham Kelsey—for raising the bar in compliance.

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  • Free E-Book: 5 Things to Expect in the Future of Regulatory Compliance

    7 November, 2016 Cindy Fazzi, Staff Writer

    Global health care spending is expected to increase by 4.3 percent until 2019, with biotech drug sales and medical device revenues forecasted to reach $445 billion and $454 billion, respectively, in 2019 (1). Given such growth, what kind of regulatory landscape can you expect? A newly released enhanced e-book offers five forecasts.

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  • Factoring Regulatory Strategy into New Product Development

    8 November, 2016 Kimberlee Washburn, Regulatory Compliance Associates

    It is unfortunate that so many new medical devices and new generation product launches are delayed due to the absence of regulatory input at the beginning stages of design control and the new product development process.

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  • Optimizing Outsourcing Options for Small Sponsors

    10 November, 2016 Laurie Meehan, Social Media Manager Polaris Compliance Consultants, Inc.

    What can small sponsors do to secure the outsourcing resources they need as large CROs form strategic alliances with Big Pharma?

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  • Process Validation: Life Cycle Approach Beats Crossing Your Fingers

    15 November, 2016 David Jensen

    f you do something right three times, you should be able to do it that way always. If this is your approach to process validation, Hal Baseman, chief operations officer at ValSource LLC, begs to differ. Baseman shared some insights about improving process validation at the PDA/FDA Joint Regulatory Conference in Washington D.C., Sept. 12-14.

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  • 5 Lessons Quality Pros Can Learn from Brad Pitt and Angelina Jolie’s Split

    17 November, 2016 Lisa Weeks

    As the saying goes, breaking up is hard to do. And while switching EQMS providers isn’t quite as heart-wrenching as switching life partners, it can be tough to let go. After all, you have a lot invested in the relationship, and the thought of starting over with someone or something new can be scary. However, sticking with an unsatisfying software solution that doesn’t add value out of convenience is even scarier. You owe it to yourself to move on. If you are thinking of ditching your current EQMS for another—or want to upgrade from a paper-based QMS to an electronic one—take these lessons to heart:

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  • Process Validation Habits You Should Quit Cold Turkey

    22 November, 2016 Lisa Weeks

    It’s that time again. Time to loosen our belts and get ready to eat ourselves into a food coma feasting on hot, delicious gravy-laden turkey. With turkey on the brain, I started wondering about the phrase “going cold turkey” and how it came to mean the act of quitting something (e.g., substance, behavior or habit) suddenly. And more importantly, when we should do it.

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  • GCP Compliance: Eliminating Silos between Clinical Quality and Clinical Operations

    29 November, 2016 Patricia Santos-Serrao

    In a classic episode of Seinfeld, George Costanza is terrified of the potential ramifications of his “worlds colliding” when his fiancée, Susan, becomes friendlier with his dubious pals Elaine, Kramer and Jerry. “Everybody knows you’ve got to keep your worlds apart,” George rants (but when does George not rant?) “If Susan is allowed to infiltrate this world then George Costanza as you know him ceases to exist. If Relationship George walks through this door, he will kill Independent George! A George divided against itself cannot stand!”

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  • Better IT Tools Mean Better Results

    1 December, 2016 David Cornwell

    An essential and growing component of the workforce, knowledge workers are those individuals whose primary role is the creation or management of information. Document collaboration is an increasingly common component of these workers’ daily tasks. In fact, research conducted for PleaseTech by Osterman Research reveals that during a typical month, knowledge workers create an average of 36 documents on which they will need to collaborate with others, while also being asked to collaborate on a further 34 documents. That total of 70 documents a month equates to an average of more than three documents a day.

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