Feb 11, 2016

When Is A CRO Not A CRO? (And why does that make enforcement hard?)


 It looks like a CRO.
It sounds like a CRO.
But is it really a CRO?

by Jamie Colgin

Colgin Consulting

What do the following types of companies have in common?
  • Electronic data capture (EDC) software providers
  • Central image / electrocardiogram (ECG) / spirometry readers
  • Central clinical labs
  • Electronic patient reported outcome (ePRO) software providers

They're not Clinical Research Organizations.
That's right. They're not CROs.

Feb 9, 2016

FDA Issues Draft Cybersecurity Guidance for Device Manufacturers

FDA has issued a draft guidance medical device 
manufacturers should take to address cybersecurity risks.

by James C. Gavejian, CIPP

Principal

Jackson Lewis P.C.


Reprinted with permission

Last week (January 22, 2016), the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have entered the market, is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices in the face of potential cyber threats.

Feb 4, 2016

CLIA vs QSR (What You Don’t Know Can Hurt You)


The Clinical Laboratory Improvement Amendments (CLIA)established quality standards to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.

This two-part series will discuss the ramifications and realities of the FDA’s increased interest in laboratory developed tests (LDTs) in CLIA laboratories.  CLIA labs and the tests that they develop and offer have largely gone untouched by the FDA until recently (we did not say unnoticed….).  Recent draft guidance issued by the FDA (FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs); Oct 2014) reaffirms the FDA’s interest in these tests and their awareness of this segment of the industry.

Feb 2, 2016

One Q & a Lotta A’s about SOPs for Research Sites

SOPs or work instructions---
which does a clinical research site need?


by Laurie Meehan

Social Media Manager

Polaris Compliance Consultants, Inc.

Posted on LinkedIn in 2015:

“What are your thoughts about having SOPs for clinical research sites versus having working guidelines in lieu of SOPs?”

You know how it is with those LinkedIn discussion groups.  You think you’re posting an intriguing and brilliantly conceived question that will inspire your colleagues to clear their desks, seize their keyboards, and plunge headlong into enthusiastic electronic debate. Instead, your post lands unceremoniously on the ground, with only the dullest of thuds, ignored and unloved.  

Jan 28, 2016

People Don’t Fail, Processes Do

When a situation goes wrong, 
look at your process and ask why.

by Terry Smith

Lean Enterprise Institute


Lean isn’t only a mindset. It gives you and your organization tons of tools and techniques you can apply immediately to improve your business processes. One of my favorites is the 5 Whys. It’s the best demonstration I think of how in fact, people don’t fail, processes do.

In short, 5 Whys is a quick root-cause analysis. Sakichi Toyoda invented this approach in the Toyota Motor Corporation to analyze the defects in processes.

Jan 27, 2016

The FDA Just Called! Are You Ready for an Inspection?

If the FDA calls to schedule an 
inspection, will you be prepared?

by David R. Butcher

Marketing Communications, MasterControl


If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you go into panic mode or would you go on with your day, business as usual? For many, an FDA inspection can be a scary prospect. It can be extremely difficult, and failing it can have significant consequences. With proper preparation, however, the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.

In a recent webinarUnderwriters Laboratories’ (UL) Linda Chatwin and MasterControl's Walt Murray shared their wisdom on the value of FDA audit readiness.

Jan 26, 2016

How to Respond to FDA Inspection Observations, Including Those You Dispute



by Martin Browning, President, EduQuest, Inc. 

FDA expert investigator and rule-maker for 22 years

Although FDA is strapped with limited resources and competing priorities, the Agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters.

In 2014 alone, FDA conducted more than 38,000 inspections and issued 8,457 Form 483s -- inspection observations that, in the inspector’s judgment, indicated an operation or product violated FDA requirements. 

To maintain this enforcement pace while replacing an aging workforce, FDA has hired a number of new inspectors. Although some “veterans” remain, it’s highly possible your next inspection will be conducted by one of the Agency’s less experienced investigators. 

Lacking industry-specific knowledge, new inspectors are less likely to understand and accept your explanation of unfamiliar products or processes. So if you find yourself in a situation where you disagree with a 483 observation, you need to know how to respond effectively and responsibly to keep a minor dispute from escalating to a major legal battle.

Jan 21, 2016

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

Medical manufacturers live in a world where 
regulatory compliance must always be considered,
 including changes associated with IEC 60601.

by Mark Leimbeck

Program Manager

UL EduNeering


Clarification of "Essential Performance"


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.   



The impact of these two changes was far-reaching, in that the concepts associated with mitigating basic safety risks (fire, electric shock and casualty) are well understood; however the concept of essential performance was new for many, and mitigating their risks even more of a challenge.  Further complicating this situation was the fact that the 3rd Edition was the first attempt at including a requirement for performing an assessment of a process (in this case, the risk management process) in the context of a type examination test standard.  As may have been anticipated given this background, Amendment 1 was largely focused on clarifying what the authors intended with respect to assessing the essential performance of a device, as well as how to assess a risk management process in the context of a type examination standard.  

Jan 19, 2016

New Developments in IEC 60601 Amendment 1 & Risk Management: Part I

by Mark Leimbeck

Program Manager

UL EduNeering


Assessment of Production & Post-Production Information


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.  

The impact of these two changes was far-reaching, in that the concepts associated with mitigating Basic Safety risks (fire, electric shock and casualty) are well understood; however the concept of Essential Performance was new for many, and mitigating their risks even more of a challenge.  Further complicating this situation was the fact that the 3rd Edition was the first attempt at including a requirement for performing an assessment of a process (in this case, the risk management process) in the context of a type examination test standard.  As may have been anticipated given this background, Amendment 1 was largely focused on clarifying what the authors intended with respect to assessing the essential performance of a device, as well as how to assess a risk management process in the context of a type examination standard. 

Jan 14, 2016

Do You Really Want to Be An Executive In An FDA-Regulated Company?



If you don't want a visit from the 
Department of Justice, pay attention 
to the new enforcement policies 
the DOJ is following.

by James R. Phelps 

Hyman Phelps & McNamara, P.C


Reprinted with permission.  First appeared October 22, 2015 in FDA Law Blog.

Last Thursday, at the 16th Pharmaceutical Compliance Congress and Best Practices Forum, Principal Deputy Assistant Attorney General for the Justice Department’s Civil Division, Benjamin Mizer, reviewed enforcement policies that the Department of Justice will follow.  Appropriate to the forum, he focused on the industries regulated by FDA.  The emphasis he gave to the requirements for settling civil and criminal cases brought against organizations gives sharp focus to the problem of doing business when governed by a law that operates with a malum prohibitum standard of liability, a law that permits findings of criminal guilt without proof of intent or guilty knowledge.

Jan 12, 2016

6 Ways Quality Managers Can Build a Culture of Quality



Agreeing on a definition of quality
is just one way to foster a culture of
quality in your company.

by Beth Pedersen, Marketing Communications Specialist, MasterControl

If you’re a quality manager, you have a demanding job. In a nutshell, you’re responsible for ensuring satisfactory and consistent quality throughout every successive step of the development of your products and services, a duty which requires you to wield a massive skill set and wear many different hats. Your daily existence revolves around quality; you dissect it and measure it and evaluate it and analyze it; you sleep, eat and breathe quality. And yet, how often do you really contemplate the concept of quality, and what it means to your company beyond the daily rigors of meeting customer requirements and upholding mandatory regulations and standards?

Jan 7, 2016

How to Ensure You are Following the ISO 9001 Certification Process

These tips help ensure you are 
following the correct processes 
for successful ISO certification.


by Stuart Patch

Content Writer

Compass Assurance Services


A key requirement of any investment is that it adds value to your business/organisation. ISO 9001 Quality Management System (QMS) is one of the world’s most widely implemented standards, but it can be quite confusing at times. Below I break down some of the key certification requirements and give some tips to ensure you are following the correct processes for a successful certification.