• Understanding FDA’s UDI Guidance: The Key to Compliance

    13 June, 2017 by Beth Pedersen, Staff Writer, MasterControl

    The latter half of 2016 saw the second highest number of U.S. medical device recalls since 2000 with 650 medical devices and over 180 million units pulled from the market, according to Stericycle ExpertSOLUTIONS’

    Full story
  • When GCP & GMP Meet

    30 May, 2017 by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    Developing safe and effective drugs requires a coordinated effort across a diverse set of disciplines. This is easier to observe at some points in the process than at others. Once a product is well into human trials, it can be easy to forget that developments on the manufacturing side of the house can affect the clinicians who are conducting the studies.

    Full story
  • What Is a Document Control System?

    12 May, 2017 David Jensen, Staff Writer, MasterControl

    Being in the regulated manufacturer arena, you have heard that oft recited phrase “if it isn’t documented, it didn’t happen.” This motto shared among life sciences companies means an efficient document control system is at the core of quality management. Documents and records serve as proof that your company follows good manufacturing and document management practices required for compliance.

    Full story
  • 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
  • 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
  • Mayday! Mayday! These "Unknown Unknowns" Can Torpedo Your QMS

    19 August, 2016 by Walt Murray; CLA, CSSMBB ARC Experts

    In psychology, people talk about knowledge and learning in terms of four levels: what we know, what we think we know, what we know we don’t know, and what we don’t know we don’t know. In the life sciences, the fourth level, what we don’t know we don’t know (or unknown unknowns, for short), carries the most risk in quality and compliance. If you are in a leadership position, the risks are even higher. After all, how can you provide the appropriate resources or strategic direction while operating in a knowledge void?

    Full story
  • Top 5 Medical Device Trends of 2016

    26 May, 2016 Lisa Weeks, Marketing Communications, MasterControl

    Ben Franklin said, “When you’re finished changing, you’re finished.” That’s advice medical device makers can take to heart because 2016 really is shaping up to be a year of unprecedented industry change. Non-traditional medical device companies, such as Google and Apple, are entering the space, disrupting the business models of major industry players.

    Full story
  • The FDA Just Completed Its Inspection...Now What?

    12 May, 2016 David R. Butcher, Marketing Communications, MasterControl

    Even after an FDA investigator has completed an inspection at your facility, there’s still plenty of work that remains. At the conclusion of an audit, the inspector will hold an exit interview to discuss observations and present significant findings on a Form 483. What do you do next?

    Full story
  • Compliance, Innovation and GMPs at the 32nd SQA Annual Meeting & Quality College

    4 April, 2016 Robyn Barnes, Marketing Communications, MasterControl

    If you’re not cultivating a culture of quality at your workplace, what are you doing to improve compliance, innovation and good manufacturing practices (GMPs)?

    Full story
  • New Developments in IEC 60601 Amendment 1 & Risk Management: Part 2

    21 January, 2016 Mark Leimbeck, Program Manager UL EduNeering

    When the 3rd Edition of IEC 60601 was published, two significant changes from the 2nd Edition were introduced: first, an expansion in the scope of the Standard from basic safety (only) to include essential performance; and second, introduction of a requirement for assessment of the risk management process applied by manufacturers in developing their medical devices.

    Full story
  • Inspecting Clinical Trials - MHRA on the Trial Master File

    9 September, 2015 Gail Francis, Expert Inspector, GCPMHRA

    The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed. This blog highlights some of the issues which have been experienced by sponsors and inspectors attempting to manage and review the large amounts of documentation that exist in support of a trial.

    Full story
  • Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

    28 July, 2015 Kelly Thomas, Atlantic Validation

    Successfully completing a FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection management techniques can help mitigate the risk of receiving an observation for compliance gaps. This article will provide insight on understanding the inspector, discuss how to prepare for and manage the actual Inspection, describe follow-up activities required for close-out, as well as describe real-life lessons learned.

    Full story
  • 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?

    Full story
  • 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.

    Full story
  • Cosmeceuticals: the Good, the Bad and the Ugly

    19 May, 2015 MasterControl

    Since retiring from FDA, I have assisted numerous businesses in developing labels for “Cosmeceuticals.” I have also presented a number of training programs on the manufacturing and marketing of such products. When I was asked to write something using this specific title, I thought I would be able to quickly put an article together. At first, I had a difficult time putting pen to paper because I couldn’t think of anything “ugly” about cosmeceuticals as I define them. To get started I searched the Internet to see what others were saying about these products.

    Full story
  • The ISO 9001: 2015 Change Train is Gathering Steam

    6 May, 2015 Robyn Barnes, Marketing Communications, MasterControl

    ISO change is coming your way in the form of an ISO 9001 update.  This is a major revision to the standard and pharma companies need to prepare to jump on this train. 

    Full story
  • Creating a High Performance and Low Risk Work Culture

    5 May, 2015 David Patrishkoff, President, E3- Extreme Enterprise Efficiency

    Most of us have heard the phrase: "Culture eats strategy for breakfast." It could also be restated as "Your actions speak louder than your words." This means that management can dream up any strategy they want to but their behaviors and actions are what creates the culture of an organization, not their strategy. Culture drives the efficiency of an organization's processes. The culture drives the success or failure of an organization. The culture is the product of leadership decisions or the lack

    Full story
  • Cut through the Clutter: Simplifying Regulatory Compliance

    29 April, 2015 David R. Butcher, Marketing Communications, MasterControl

    For any business, the process of getting a product to market – from concept initiation through release – is often long and arduous. For manufacturers that must navigate the maze of regulatory red tape, hoops and hurdles, the process of bringing an innovative product to market can be even more punishing and the stakes even higher: one wrong step can stall or completely derail the entire product development effort, giving competitors a major advantage in the race to market. race to market.

    Full story