GxP Lifeline

From Smart to Brilliant and Beyond: 3 Ways AI Is Changing Manufacturing

5 December, 2018 by Beth Pedersen, Staff Writer, MasterControl

Artificial intelligence (AI) offers unprecedented opportunities for productivity and economic growth in manufacturing and other key industries. Manufacturers are already leveraging AI on the factory floor in highly innovative ways and seeing measurable results.
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The Importance of Knowing What You Don’t Know About Drug Development

4 December, 2018 by Arvilla Trag, RAC, Consultant, BioProcess Technology

New drug development is Sunday drive, especially for startups. There can be costly mistakes and unanticipated roadblocks that pop up when you least expect it. Learn how to steer clear of hazards, what to do and who to talk to.
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The Medical Device Single Audit Program: Accessing International Markets, Part 1

29 November, 2018 Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner

Regulatory change is a near constant in the medical device industry. One of the newest systems to the international medtech scene is the Medical Device Single Audit Program (MDSAP). Find out what is required to implement MDSAP in this first of a three-part series
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How Supervillains Could Benefit From a Manufacturing Operations Solution

27 November, 2018 by David Jensen, Staff Writer, MasterControl

In the epic good vs. evil paradigm in superhero movies, supervillains could actually improve their odds if they used the right technology. This article looks at three noted supervillains and discusses how their nefarious agendas might have been more successful had they used a digital manufacturing operations solution.
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Planning Ahead for Transition to the EU's MDR: A How-To Guide, Part 2

20 November, 2018 by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health

Preparing for the transition to the European Union’s Medical Device Regulation (MDR) requirements is proving more formidable than some medical device manufacturers originally anticipated. This is part 2 of blog series about what kind of challenges medtech companies are experiencing and how you can create a workable transition plan.
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Planning Ahead for Transition to the EU’s MDR: A How-To Guide, Part 1

19 November, 2018 by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health

Medical device manufacturers are finding it more difficult than initially anticipated to prepare for the European Union’s (EU) Medical Device Regulation (MDR) transition period, which ends May 2020. Find out what kind of challenges medtech companies are experiencing and how you can create a workable transition plan in this two-part blog series.
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Building an Audit-Ready QMS

15 November, 2018 by Joy McElroy, Consultant and Business Development Director, Maynard Consulting Company

Consumers and patients assume manufactured pharmaceuticals are safe and effective. In order for quality units to assure this, you have to have a robust quality control (QC) and quality assurance (QA) program guided by an equally sound quality management system (QMS). Learn the roles of QC and QA and how to create a QMS that will help your company maintain a high level of quality.
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PwC Report Analyzes Health Care Policy Issues

15 November, 2018 by PricewaterhouseCoopers Health Research Institute

PwC’s Health Research Institute recently issued a report on the U.S. midterm election that analyzes policy issues that may well impact the American health care industry for years to come, particularly those in the pharmaceutical and life science industries. Learn what this means for manufacturers.
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Quality Assurance and Quality Control: What's the Difference When It Comes to Managing Quality?

13 November, 2018 by Kimberlee A. Washburn, Regulatory Affairs Author

Quality assurance and quality control functions in the manufacturing process may share some similarities but they’re actually quite different animals. Learn about the purpose of each and their relationship to each other in enabling life sciences and other regulated manufacturers to maintain a high level of quality and compliance for their products.
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Top 5 Nutraceutical Trends in 2018 - Conducting Clinical Trials on Nutraceuticals

8 November, 2018 by Sarah Beale, Staff Writer, MasterControl

Nutraceutical companies have never been required to conduct clinical trials. However, many are now voluntarily taking on this endeavor to show that their products work as advertised. This adds legitimacy to nutraceuticals and provides a better value for consumers, but the complexity of clinical trials presents a significant hurdle.
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Risk Management and the Human Species

6 November, 2018 by Rai Chowdhary, CEO and Founder, The KPI System

Science has shown that human beings are not immune from making irrational choices when it comes to risk management, even in the life sciences. This can have significant effect on manufacturing processes, and ultimately, patients. Learn how to avoid falling into this trap.
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Advancing the Regulatory Profession in Utah

1 November, 2018 by Robert M. Wolfarth, Chairman, RAPS Utah Chapter

Based on recent economic study and the establishment of the Silicon Slopes technology corridor, Utah has one of the fastest-growing life sciences communities in the U.S. Learn about the Regulatory Affairs Professionals Society’s (RAPS) new Utah Chapter and what the organization is doing to attract more regulatory affairs experts to life sciences careers.
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Top 5 Nutraceutical Trends in 2018 - Getting Creative With Protein

30 October, 2018 by Sarah Beale, Staff Writer, MasterControl

The protein supplement category is no longer exclusively for hardcore athletes. The general population is now full of people who are concerned that they’re not getting enough protein in their diets. These consumers are increasingly turning to supplements to fill the void.
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De Novo Becoming Faster and Easier Pathway to Market

25 October, 2018 by David Jensen, Staff Writer, MasterControl

There are many pathways to bring a medical device to market. The 510(k) and premarket approval (PMA) are the most common, while the de novo pathway is less popular. Advances in technology and changes in regulatory standards are making the de novo a more attractive option.
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What's Hiding in Your Labeling Artwork?

23 October, 2018 by Dan Vuksanovich, Regional Sales Manager, Schlafender Hase

Because there are potential but invisible risks inherent in labeling artwork documents of life science companies that can’t be detected through manual proofreading, it’s important to be thorough and to know the tricks to detect and prevent these snags from causing unnecessary delays in the manufacturing process.
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Advancing the Case for Quality in Medical Device Manufacturing

18 October, 2018 by Stephanie Christopher, Program Director, Medical Device Innovation Consortium

We all seek quality in goods and services, but how can that quality be assured? The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH), as part of its Case for Quality initiative, last year launched the Voluntary Medical Device Manufacturing Product Quality pilot program based on a maturity model as an alternative to the traditional path of a routine FDA inspection. Find out if the program might be the right step to boost your company’s quality and compliance.
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BraveHeart Team Emphasizes Quality-First Approach

16 October, 2018 by David Jensen, Staff Writer, MasterControl

One trap regulated startups should try to avoid is having unrealistic assumptions about what it takes to achieve compliance. Part 3 of this article series features several members of the BraveHeart team discussing their views and expectations for quality throughout the Wearable Life Sensor’s life cycle.
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FMEA Without Tears: A Prescription to Reduce Pain and Confusion

11 October, 2018 by Rai Chowdhary, CEO and Founder, The KPI System

Failure modes and effects analysis (FMEA) is a particularly effective tool in risk management. But its use is often accompanied by fear or pain because practitioners struggle to apply it. Learn how to effectively use FMEA without trepidation to improve your company’s risk management operations.
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Airplane Preflight Check Exemplifies Quality in Med Device Design

10 October, 2018 by David Jensen, Staff Writer, MasterControl

Before any aircraft leaves the ground, it undergoes a preflight check. Part 2 of this series on BraveHeart features Steve McCalmont performing an aircraft preflight check to illustrate how this critical part of flying equates to the importance of incorporating quality in the design of a medical device.
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Getting Paid: A Shifting Medical Device Reimbursement Landscape in Australia

9 October, 2018 by Sarah Griffin, Principal Consultant, Brandwood Biomedical (Australia)

Australia is increasingly an attractive market for medical device manufacturers. But medtech companies need to know the complexities of the country’s blended public and private hospital systems to avoid confusion and fully profit from its device reimbursement opportunities.
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