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Sep 7, 2017

We've Moved

GxP Lifeline Reader,

Thank you for visiting MasterControl BlogSpot. We have recently transitioned to posting GxP Lifeline to our new website. It can be found under the Resources Tab at MasterControl.com. You can easily access it here MasterControl.com/GxP-Lifeline.

                                  Thank You,
                               

Sep 5, 2017

Add Cybersecurity Education to Every Employee’s Job Description

Cybersecurity training adds another
level of security to your company's
technology infrastructure

by David Jensen

Staff Writer
MasterControl


The recent surge of security breaches and ransomware attacks is reinforcing the need to make cybersecurity an all-hands endeavor. Despite all the cybersecurity tools that companies are implementing, security breaches are still rampant because one of the top cybersecurity weaknesses in all industries is the lack of training employees on cybersecurity.

Cybersecurity has largely been rooted in intrusion detection and prevention technology designed to protect your network infrastructure, databases and system software. However, one error on the part of an employee could render all your security measures useless. This where training your employees on the latest cybersecurity trends and tactics is vital to your organization’s security efforts.

Aug 31, 2017

How to Lead with Respect

Orzen says that companies aren't 
experiencing employee engagement 
because they neglect the
"Respect for People" pillar.


by Doug Bartholomew


Editor’s Note:  Not all posts are created equally.  Some are more popular than others.  Leading people in today’s high tech, fast-paced business world is always a challenge.  Good articles on the subject always rate well with our readers, and this is one of the year’s most popular posts.  If you’ve not read it before, we hope you enjoy it.  If this is your second time reading it, we hope you glean new insights.

“Over time I’ve come to realize that engaging in this problem-solving process is actually the highest form of respect….The manager truly respects the employee’s knowledge and his or her dedication to finding the best answer….Only by showing mutual respect-- each for the other and for each other’s role-- is it possible to solve problems, make work more satisfying, and move organizational performance to an ever-higher level.”
                                           --Jim Womack, Gemba Walks, Expanded 2nd Edition, p. 5

At every organization that has embarked on a lean transformation, managers are well aware of the need to “show respect” for their people. In fact, respect for people is one of the pillars of the Toyota Way. Thus, when asked, lean managers will tell you that “employees should be treated fairly, given clear goals, trusted to achieve them in the best way, and held accountable for results,” writes Jim Womack, lean management expert and founding CEO, Lean Enterprise Institute (LEI).

Aug 29, 2017

Medical Device Safety and Quality Data: Reduce Risk, Improve Patient Safety

Medical devices have received a lot of
negative attention lately.  Duodenoscopes
such as this are among the devices
receiving adverse event coverage.

by Nicolas Tasse-Guillen & Daniel Henrich, 

Reed Tech Life Sciences Team


Medical Devices in the Spotlight


Medical devices have received quite a bit of media attention recently and, unfortunately, much of that attention has been negative. High profile stories have appeared in major media outlets online, in print and on TV about adverse events resulting in patient harm from permanent contraception, power morcellators, duodenoscopes and other high-risk devices.

Aug 24, 2017

Thoughts from 2017 PDA Quality Metrics and Quality Culture Conference


The FDA's metrics program is intended
to improve the quality of drugs.

by Stephanie Gaulding, CQA, CPGP


DPS Engineering


Note: The original version of this article was published on my LinkedIn profile on February 23, 2017. Another version was published in the July/August 2017 issue of PDA Letter.

I had the pleasure spending two days networking and discussing quality metrics and quality culture with industry and FDA leadership at PDA's 2017 Quality Metrics and Quality Culture Conference last February. This year's conference included some of the most candid and honest dialog on these topics that I've seen between industry and FDA to data. I thought I would share some of the messages and my takeaways from the two-day event.

Aug 22, 2017

Avoiding CAPA Pitfalls: 10 Tips from a Food Industry Quality Expert


ASQ speaker Jack Hamilton shared best practices
for avoiding problems in managing
corrective and preventive action (CAPA) systems.

by James Jardine


MasterControl Staff Writer


At a recent ASQ Salt Lake Section symposium held at the headquarters of quality management software solutions provider MasterControl in Salt Lake City, food safety expert Jack Hamilton of EAGLE Certification Group shared some best practices for avoiding problems in managing corrective and preventive action (CAPA) systems.

While CAPA issues are relevant to every manufacturing environment, the CAPA approach that Hamilton takes is food safety management-centered, as that is his area of expertise in his position as senior business development manager with EAGLE. His presentation focused on CAPA as it relates to the SQF Code, the preeminent standard of quality for food production. He compared an organization’s CAPA system to a fast car and the superhero Iron Man, saying, “you don’t want to let it get rusty, or it’s useless.”

Aug 17, 2017

Nuts and Bolts of 510(K) Submissions

There's no getting around the
rules for 510(k) submissions.


by Rob Packard


President


Medical Device Academy, Inc.


A 510(k) is pre-market notification of medical devices to the US FDA. The number “510” refers to section of the Food, Drug and Cosmetic Act. “k” is the subsection specific to pre-market notification. Details regulating the process, however, are found in 21 CFR §807.

The current device classification system consists of three-letter product codes for each device type. Each classification is designated as Class I, Class II or Class III. Class I devices are considered low risk and require only “general controls.” Class II devices are considered moderate risk and require “special controls.” Finally, Class III devices are high-risk devices that typically require a clinical study to demonstrate safety and efficacy. The FDA only “approves” these Class III high risk devices. All other device classifications are not “approved” by the FDA via the pre-market approval (PMA) process.

Aug 15, 2017

What Is a Quality Control System and How Can an EQMS Improve On It?

Although it may identify problems and
facilitate ways to resolve them, a quality
 control system alone does not ensure quality.


by David R. Butcher


Staff Writer

MasterControl 


For organizations doing business in regulatory environments, successful quality assurance and quality control are crucial aspects of quality management in FDA- and ISO-regulated environments. Often, “quality control” and “quality assurance” are used interchangeably, referring to the activities conducted to ensure the quality of a product, service or process. While some quality control and quality assurance activities are interrelated, however, the two are not necessarily interchangeable

Aug 14, 2017

Regulatory Strategies for AI and Emerging Technologies



AI and machine learning are at an early
stage but offer great potential
for improving medical care.

by Steve Tyrell, Senior Director, Business Development, Regulatory Compliance Associates Inc.


and


Lisa L. Michels, General Counsel and Regulatory Affairs Expert, Regulatory Compliance Associates Inc.


Insights on working with regulatory bodies on novel devices such as artificial intelligence, machine learning and algorithms.

When powerful new technologies emerge, unbridled excitement often reigns.  The possibilities are endless and markets are undoubtedly huge.   Artificial intelligence and machine learning in medicine are at an early stage and the potential to improve medical care is solidifying.  Many opportunities are being pursued including enhancing and supporting the decision-making process of physicians, individualizing patient care with precision medicine and using near real-time information to improve care.

Aug 8, 2017

6 Opportunities and Challenges Combo Product Makers Should Be Aware of in 2017



by Alex Butler


Manager, Medical Device Solutions


MasterControl



Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that merge two or more different types of regulated drugs, medical devices or biologics into one multi-faceted treatment. As more device and pharma companies join forces to develop combo products, the traditional industry and regulatory boundary lines between the two sectors become blurred, presenting medical product makers with as many opportunities as challenges.


This excerpt from my recent MDDI Device Talk blog post highlights some of the advantages and growing pains to keep in mind if you are considering making the move into the combo product space in 2017.

Aug 3, 2017

Is The 510(k) Process As Worthless As The Federal Courts Seem to Believe?

It is time for the Supreme Court
to remedy the Federal Courts'
understanding of the 510(k) process.

by Jeffrey K. Shapiro


Hyman, Phelps, McNamara, P.C.


Does the Food and Drug Administration’s review of medical devices in the 510(k) program involve a substantial review of safety and effectiveness? FDA says it does (p. 44). Device makers and those of us who practice in this area know how burdensome and extensive this process can be. It requires device makers to provide extensive preclinical safety and effectiveness data for FDA’s review. Depending upon the type of device, FDA may also require clinical data. We wrote a Food and Drug Law Journal (FDLJ) article in 2014 describing the evolution of the 510(k) program and its current‑day rigor.

Aug 1, 2017

UDI as Med Device Product Tracking Software (Why That’s a Good Thing)


by Cindy Fazzi


Staff Writer



When the U.S. Food and Drug Administration (FDA) mandated the use of unique device identification or identifier (UDI), some people voiced concerns over the high cost of the requirement, as well as the technology challenges it posed. What is UDI and why is it important?