GxP Lifeline

Showing items tagged as Risk Management

Supply Chains Are High Risk For Hardware Hacking

14 March, 2019 by David Jensen, Staff Writer, MasterControl

The discovery of a mysterious microchip in servers used in U.S. government offices further blurred the line between fiction and reality. While network and software hacking dominates the cybersecurity spotlight, hardware often goes unnoticed and unprotected. Hence, companies are highly encouraged to give some much-needed attention to supply chain security.
Full story
2019 Med Device Trends to Watch For: Human Factors Engineering

6 March, 2019 by Cindy Fazzi, Staff Writer, MasterControl

To err is human, but if medical device manufacturers can mitigate hazards associated with user errors, so much the better. The U.S. Food and Drug Administration (FDA) requires human factors engineering (HFE) in device development precisely for this reason. Expect HFE to be more important than ever, according to industry experts
Full story
Recall Blunders: How to Avoid Them and How to Recover

29 January, 2019 by James Jardine, Staff Writer, MasterControl

Even the slightest oversights or errors can lead to product recalls. Learn about the primary causes of recalls, how regulators classify recalls, the four critical steps of recall recovery, and strategies that can help you avoid recalls altogether.
Full story
Despite a Focus on Risk Management, Why Do Unthinkable Things Continue to Happen?

3 January, 2019 by Rod Farrar, Director, Paladin Risk Management Services

Accidents and errors, in life and in manufacturing more specifically, continue to happen despite heightened levels of risk management and international standards. Find out why time, frequency and probability can’t be factored in to calculate likelihood and learn the key to determining actual risk.
Full story
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.
Full story
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.
Full story
Top 5 Medical Device Industry Trends in 2018: Software Is More Common and Complex

9 August, 2018 by David Jensen, Staff Writer, MasterControl

The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.
Full story
Noteworthy Clinical Trends in Med Device to Watch in 2018

5 July, 2018 by James Jardine, Staff Writer, MasterControl

Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.
Full story
Top 5 Medical Device Industry Trends in 2018: Atypical Medical Device Technology Will Become More Typical

28 June, 2018 by David Jensen, Staff Writer, MasterControl

Technology companies outside of the health care sector continue to carve out a niche in the medical device industry. This trend makes the competition more flammable. Still, in many ways, disruptive technology developers may need to call upon their incumbent counterparts for assistance with navigating the regulatory pathway to compliance. This article discusses some of the regulatory stumbling blocks that could impact non-traditional medical device developers.
Full story
Medtech Startups: How to Survive Cutthroat Competition

19 June, 2018 by Matthew M. Lowe, Executive Vice President, MasterControl

In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years. If you’re a startup, is it time to sit back and relax? Hardly.
Full story
Why Fraud Control Plans Are Completely Unnecessary

3 May, 2018 by Rod Farrar, Director, Paladin Risk Management Services

With risk management, governments and companies often rely on having a fraud control plan. But typically, a risk register is more effective at detecting, responding to and preventing various types of organizational fraud.
Full story
UK's MHRA Issues Final Guidance on GxP Data Integrity

19 April, 2018 by Mark Schwartz, Director, Hyman, Phelps & McNamara

Glean some insights from the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).
Full story
Complaint Analysis: Don’t Forget the Work You’ve Already Done

5 April, 2018 by Jake Walton, Corporate Operations Quality Manager, MasterControl

This month's tip concerns complaint analysis, and the fact that much of the labor of collecting the information for this quality step has already been recorded in writing during the pre-market phase by quality personnel.
Full story
HIPAA Compliance and Data Security Demand Equal Attention

2 November, 2017 by David Jensen, Staff Writer, MasterControl

The Health Insurance Portability and Accountability Act (HIPAA) established by the U.S. Department of Health and Human Services (HHS) has been around since 1996. The components of HIPAA cast a wide net over regulations involving insurance coverage, medical records and tax rules. However, rapidly advancing technology and security threats are pointing a spotlight on the Privacy and Security rules that apply to electronic protected health information (ePHI).
Full story
Risk Mitigation in Clinical Research: It Starts with Study Startup

31 October, 2017 by Craig Morgan, Marketing and Brand Development, goBalto

For clinical research, Study Startup (SSU) is the pivotal period that lays the groundwork for a successful study. By ensuring that the right sites are selected and target subjects are recruited in a timely and cost-effective manner, mission critical risks can be avoided that lead to runaway costs and delays.
Full story
Supply Chain Risk Management: An Ever-Changing Mosaic

19 September, 2017 Geary W. Sikich, Principal, Logical Management Systems Corp.

We have recognized the need to better manage supply chain risks for the nearly two decades now. Yet, we still seem to be deluded into thinking that the modern supply chain is resilient to the point of invulnerability.
Full story
Top 5 Takeaways from MedTech Intelligence’s Medical Device Cybersecurity Conference

11 April, 2017 David Jensen, Staff Writer, MasterControl

I recently attended a conference on Medical Device Cybersecurity hosted by MedTech Intelligence held March 23-24, in Washington, DC. It’s evident that cybersecurity is an important concept as attendance, both in-person and remote, was high. Conference organizers lined up a powerhouse group of presenters who are all entrenched in the technology, cybersecurity, legal and regulatory compliance industries.
Full story
FDA Guidance Answers Questions Regarding Data Integrity

23 March, 2017 by David Jensen, Staff Writer, MasterControl

An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “
Full story
Your Top 10 Questions About ISO 13485:2016—Answered!

2 February, 2017 by Lisa Weeks, Staff Writer, MasterControl

In early 2016, the International Standards Organization (ISO) published the long-awaited revised version of ISO 13485:2016, the standard which provides device makers with a framework for establishing a quality management system (QMS). Because it is the first major revision to the standard in 13 years, questions abound. In this post, we will tackle the most common questions asked by attendees during the many ISO 13485:2016-centric webinars we offered last year. We will also tap into the expertise
Full story
Your Suppliers’ Risk Is Your Risk

14 July, 2016 By Carrie Mantey

In today’s day and age, in which outsourcing can be the norm, and not only major global corporations stretch across the globe, but also potentially mid-market and mom-and-pop suppliers, supply chains are no longer insulated from external or environmental risk events. These risks can range from a natural disaster, such as the Japan earthquake and tsunami, to lax safety policies, in the case of the Bangladesh garment factory collapse, to the regular ebb and flow of business, including when a supplier is acquired or goes out of business. These risks are not new to the supply chain, but as the supply chain grows more complex, so do the risks to supply, especially when visibility is blurred, suppliers are far-flung and there is no backup plan in sight.
Full story