June 8, 2017
By Vivian Bringslimark, President and Owner, HPIS Consulting, Inc.
While training may appear to be straightforward to most leaders, the effectiveness follow up is anything but clear-cut. So why do business leaders frown when the answer to the training effectiveness question is – it depends?
May 23, 2017
By Marci Crane, Staff Writer, MasterControl
It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.
April 18, 2017
By Karl Vahey, Director of Compliance, International RA/QA, Covidien
Why should medical device manufacturers perform failure investigations? One reason is that it is a regulatory requirement. The Code of Federal Regulations (21 CFR 820) in areas such as Non-Conforming Product, Corrective and Preventive Action and Complaint Files describes the requirements for failure investigations. Performing effective failure investigations is also good business practice which can lead to reduction in scrap and rework, process improvements and the elimination of recurring issue
April 17, 2017
By Dan O'Leary, President, Ombu Enterprises
Process validation is an essential part of medical device manufacturing but doesn't always receive the attention it deserves (and requires). The regulations provide the requirements (FDA QSR 820.75 and ISO 13485 7.5.2), but often manufacturers don't completely understand them and don't fully implement them. The consequences can be audit findings from a Notified Body or Inspectional Observations on an FDA 483.
April 4, 2017
By Paul Sanderson, Solutions Consultants Manager, MasterControl
“Quality management” is one of those terms that sounds so simple and esoteric at the same time, like DNA or free cash flow. I’m pretty sure I know what those terms mean until I start explaining them to someone.
March 21, 2017
By Christine Park, Founder and Consultant, Christine Park & Associates
Most organizations are well under way with the transition to the new ISO 9001:2015. As such you should be very familiar with the emphasis on two four-letter words found throughout the document ….
November 29, 2016
By Patricia Santos-Serrao, Director of Product Strategy, MasterControl
In a classic episode of Seinfeld, George Costanza is terrified of the potential ramifications of his “worlds colliding” when his fiancée, Susan, becomes friendlier with his dubious pals Elaine, Kramer and Jerry. “Everybody knows you’ve got to keep your worlds apart,” George rants (but when does George not rant?) “If Susan is allowed to infiltrate this world then George Costanza as you know him ceases to exist. If Relationship George walks through this door, he will kill Independent George! A George divided against itself cannot stand!”
July 19, 2016
By Dr. Christopher Joseph Devine, President, Devine Guidance International Inc
For the second time in three weeks, Dr. D was able to quickly locate another rarely cited Form 483 observation: The failure of management with executive responsibility to actually review the quality management system they have been entrusted with managing. Now granted, from time-to-time it becomes a challenging task for the management representative to circle the wagons and corral all of the management-types into the executive conference room for a meeting focused on the performance of the quality management system (QMS).
May 19, 2016
By Laurie Meehan, Social Media Manager, Polaris Compliance Consultants
SOP revision. It falls somewhere between income tax prep and colonoscopy prep on the likability scale. So why would you want to read about it? Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful. Maybe we have.
April 19, 2016
By Mark Schwartz, Director, Hyman, Phelps & McNamara
There have been at least four FDA initiatives, in the works for some time that, in the coming years, will change the way pharmaceutical (and indeed all FDA) inspections are conducted. We think you should know about these initiatives, and how they are likely to affect the way companies prepare for, and deal with, FDA inspections. Today, we are going to discuss the Program Alignment Group (PAG) plan, arguably the least controversial of the four. Over the next few weeks we will discuss the other three programs that are likely to dramatically affect the inspection landscape.
February 4, 2016
Paula Gray, Navigant & Sharon Kvistad, Navigant
Many industries including automotive manufacturers, NASA, information technology systems, and countless others suggest or even require implementation of a Quality Management System (QMS) in order to ensure products are manufactured to a high quality standard. For products like medical devices, QM systems ensure that products are not only of a high quality, or deemed “effective” to perform as they are intended, but are also safe for their intended use.
December 31, 2015
By Laurie Meehan, Social Media Manager, Polaris Compliance Consultants
The most substantial change to international guidelines in 20 years occurred earlier this year when the ICH* issued a draft addendum to its GCP guidelines, ICH E6(R2).
November 5, 2015
By Holly DeIaco-Smith, MS, HDS Consulting
In the role of a consultant, you have the benefit of seeing what works well across your client base and their shared common pain points. Because of this perspective, I’m often invited onto a project to provide guidance on best practices and practical advice on how to avoid the common pain points.
November 3, 2015
By Marci Crane, Staff Writer, MasterControl
Although a long list of candidates make up the list of “eligibles” for the 2016 Presidential election, it’s fairly apparent that the two most conspicuous candidates are, respectively, Democrat Hillary Clinton and Republican Donald Trump. These two candidates, though liked and disliked by various population pockets across the United States, have certainly managed to make names for themselves within their various areas of expertise.
The global healthcare and healthcare service market will maintain steady growth due in large part to an aging population that is living longer and to improved healthcare services in emerging markets that include China, Brazil, India, Japan, Israel, and South Korea, among others. It is interesting to note that countertrends seem to be developing in the medical device space; for example, hospital utilization of medical devices has slowed significantly, reimbursements continue to tighten, and there was a first-time global decrease (5%) in US premarket approvals (PMAs) in 2012, a trend that continued into 2013. There were also fluctuations in investor healthcare spending across 2012, drops in mergers & acquisitions deal value and deal counts, and a device tax that is adding to the squeeze.
June 19, 2014
By Jon Beckstrand, CEO, MasterControl
MasterControl has grown our reach significantly over the last 10 years—from a small provider of a narrowly focused document control product to one of the largest organizations in the world focused on helping quality and compliance professionals achieve their purpose. I have met with many of the world’s top quality professionals over the past 10 years and I have been amazed by their devotion and commitment. I have recently found myself asking the question: What drives these dedicated people? Why are they so passionate about their jobs? I believe I have found the answer and it has had a strong effect on how I view MasterControl’s mission.
May 29, 2014
By James Jardine, GxP Lifeline Editor, MasterControl
Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.
May 17, 2011
By Jim Shore, Product and Process Improvement Leader, Dynisco
The Poka Yoke method is something that improves your daily life; why not use it to make your product better, as well? The best solutions are simple, quick to implement and 100 times more effective than a 100-percent final inspection.
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