GxP Lifeline

 

  • Top 8 Ways to Reach Regulatory Compliance

    8 December, 2016 MasterControl

    Many companies doing business in regulatory environments treat compliance like another obstacle to success. However, companies that live in regulatory environments have come to understand that compliance is actually a tool that can give them a competitive advantage. Statistics show that 72 percent of senior executives at regulated companies say that ensuring compliance with regulatory requirements is one of the most important challenges in their company.

    Full story

  • CLIA-phites vs. Quality-noids: Who Will Win the LDT Debate?

    6 December, 2016 Lisa Weeks

    The FDA’s proposed guidance for laboratory developed tests (LDTs) continues to create conflict between Quality-noids, those in favor of greater FDA oversight, and CLIA-phites, those who are not. Historically, the FDA has exerted little oversight of LDTs (e.g., no premarket review or quality system requirements) but that’s changing, largely because today’s LDTs are far more complex than the LDTs of the past. Both sides agree that more oversight is needed. Which federal agency should provide it, however, has sparked intense controversy.

    Full story

  • 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.

    Full story

  • 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!”

    Full story

  • 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.

    Full story

  • 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:

    Full story

  • 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.

    Full story

  • 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?

    Full story

  • 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.

    Full story

  • 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.

    Full story

  • 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.

    Full story

  • 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.

    Full story

  • 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

    Full story

  • 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 

    Full story

  • 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.

    Full story

  • 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.

    Full story

  • 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.

    Full story

  • 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.

    Full story

  • How Well Do You Know Your FDA History?

    6 October, 2016 Lisa Weeks

    Fall is officially upon us, and we are settling into a new school year. As a child, I loved the beginning of school. It signified a fresh start

    Full story