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Jan 29, 2015

Risk Management in Clinical Research: Process and Application


Clinical Auditor, IMARC Research Inc.


Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding risk based approaches to clinical research. These documents include FDA’s “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” and EMA’s “Reflection paper on risk based quality management in clinical trials”.  The focus of the regulators on this concept initiates a discussion of how to introduce, implement, and apply risk management principles to clinical trials. The applicable guidances for good clinical practice (GCP), ICH E6 and ISO14155, state explicitly that the sponsor is responsible for quality assurance and quality control. One aspect of quality involves how risks are approached and managed throughout the course of a clinical trial, and is the focus of this article.

Jan 27, 2015

Med Device Excise Tax Debate: Let Your Voice Be Heard


Executive Vice President, MasterControl Inc.

Since January 2013, medical device manufacturers and importers have been paying a 2.3 percent excise tax as part of the Affordable Care Act. The tax is assessed regardless of the company’s profitability.

Critics say the excise tax stifles innovations and kills jobs, while supporters say it will be offset by the increased number of insured people receiving treatments.

Jan 22, 2015

Getting Ready for ISO 13485:201X (Part 1)

The quality management standard for med devices is changing.
by Lisa Weeks, Marketing Communications

As most of you know, ISO 13485–Quality Management Systems—Requirements for Regulatory Purposes is being revised. ISO 13485:201X, as the final revision is being referred to, is expected to be available in late 2015 or early 2016. Understandably, this is causing anxiety for medical device manufacturers, many of whom are still struggling to conform to the current version of the standard. With this in mind, let’s review the basics of the ISO: 13485. In future posts, we’ll examine why the standard is being updated, and the most significant changes you can expect to see. 

Jan 20, 2015

Five Steps to Building Process Efficiency with Your Supplier




In order to achieve success with your outsourced manufactured medical devices, there must be cohesiveness between the manufacturer (Supplier) and the product developer (Customer). I’ve exemplified this role as that of the supply chain liaison consultant, involved directly with the development of the manufacturing processes, while in step with the roll-out of the product design intent.  This article will discuss the five steps required to accomplish all of this while defining the role of the consultant.  The consultant provides the tools and leadership to maximize the value of the supplier in their partnership with the customer.

Jan 15, 2015

Setting an Organization's Risk Management Context


Director, Paladin Risk Management Services
There is considerable confusion in the risk world in relation to terms such as risk appetite, risk tolerance, risk acceptance, risk threshold and risk attitude (just to name a few).  These are defined differently by organisations and there is no guidance in ISO 31000 that clarifies this, so the confusion becomes a distraction.
No matter what it is called – all organisations need to specify the parameters within which they are going to manage their risks.  In order to do this there a number of fundamental questions that you need answered.

Jan 13, 2015

What Does Risk-Based Monitoring Mean for QA Auditing?

Internal Project Manager, Polaris Compliance Consultants, Inc.

By now, we all know that risk-based monitoring (RBM) isn’t just about changing the role of the clinical research associate (CRA); it’s transforming the way clinical studies are managed.  So what does that mean for quality assurance (QA) teams who audit these new processes?  Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.

It’s a slippery subject.  Traditional monitoring relied on the gold standard of on-site visits every 4-8 weeks and 100% source data verification (SDV).  RBM is not replacing this standard with another.  RBM is a framework for customizing a monitoring approach for each study, and guess what -- “custom” is a lot trickier to audit than “standard.”

Jan 8, 2015

Enter The Digital Risk Officer

In the brave new world of digital risk management, a CISO would report up to a DRO who manages risk from a business perspective and works with peers in business operations, compliance and IT security.
The business processes in the enterprise and in government organizations have become "digital" at an accelerated pace in the past few years. In most industries, many business functions that were conducted on premises or were paper-based are now being performed online and via digital processes. While this trend has led to a dramatic improvement in productivity, it has also led to a new set of risk factors that extend beyond the familiar threats to traditional IT systems.

Jan 6, 2015

Risk Management: A Primer for Lean Quality Assurance



Managing risk across an organization is now a critical skill 
that should be fully integrated with other business functions 
such as finance, strategy, internal control, procurement, 
continuity planning, HR and compliance.
by Gina Guido-Redden
Co-Founder, Coda Corp USA


In this article, we will take a closer look at what is becoming perhaps the most useful tool in the belt of today’s quality professionals: risk management.
Risk management is the new face of lean quality assurance. It is a critical planning and assessment tool that serves both consumer-centric and production activities.
This blog has been designed for readers whose organizations haven’t yet formally adopted this practice.  The installment includes an overview of the terminology, objectives and processes involved in strengthening the existing quality systems with those designed to manage the risks inherent to product development, routine manufacturing and monitoring. 

We hope that the information presented will inspire the reader to engage local leadership and promote the development of an effective risk management process that begins with the design stage of the product lifecycle and continues all the way through monitoring of routine production.