-->

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?

Jul 28, 2017

Good Communication Skills are Key for Inspection Readiness



When an FDA inspector comes to your door, it is usually a time of stress and uncertainty.  You need to handle logistical elements like where the inspectors are going to be placed, how you will gather the requested data and forms, how prepared the facility is and with whom will the inspectors be interacting.

But you must also consider whether or not the personnel in the organization are properly prepared to communicate and interact effectively with the FDA investigator.  You want your personnel to be familiar enough with the processes and procedures of the inspection to provide the best possible impression .  In short, you need to help the quality assurance, auditing and operations teams understand what’s expected during a FDA and/or EU inspection. Of course, the best way to be ready for an inspection is for your company to have your processes, procedures and documentation under control and operating in a state of compliance with regulations.

Jul 25, 2017

Not Just Tiny Humans: Considerations for Conducting Pediatric Clinical Trials

Patient recruitment for pediatric trials
is challenging but very necessary for
drug and medical device development.


by Jamie Arnott, Project Director


and


Caitlin Hirschman, Clinical Team Lead


Rho


When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.


Jul 20, 2017

5 Trends Driving Disruption in the Med Device Industry in 2017

Connected devices for seniors
may allow them to age in place.




by Lisa Weeks

MasterControl Staff Writer


The medical device industry is complex, ever-changing and highly regulated, that much we know. We also know that, despite the complexity, the outlook is rosy for device manufacturers that can recognize—and navigate—the major trends of the day. The purpose of this post is twofold: to identify the trends that are likely to have significant impact on the industry this year, and to provide some high-level tips for exploiting them. Here's a mid-year review of 2017's biggest trends---and some tips for exploiting them.



#1 Other Business Sectors Will Continue to Disrupt the Space


Google and Apple may have led the charge, but we can expect to see other business sectors vying for a piece of the health care market in 2017. “As emerging technologies are further integrated into health care, more tech and non-traditional device companies will continue to enter the space,” according to Matt Lowe, an engineer who has successfully launched more than a dozen medical devices and serves as executive vice president of MasterControl. “To stay competitive, established players will have to gain knowledge of these new technologies, or partner with companies that already have it.” 

Jul 18, 2017

How Training Personnel on Your Quality System Can Produce Positive ROI. Don’t Stop at the Quality Manager.

A company’s ROI from an online training
program can be substantial and immediate!

by Greg Peckford


Founder, Quality Career Advancement


Is the quality manager the only individual within an organization that requires training on quality and improvement methods? Absolutely not! In order for an organization to get the most value out of their quality program, and to ensure it is effective, is to train as many people as possible or even all employees, depending on the size of the company, on the concepts and strategies that its quality management system is based on.

Jul 13, 2017

FDA Favors Collaborative Approach to Medical Device Cybersecurity

Implement cybersecurity at the grassroots
level of medical device development

by David Jensen


MasterControl Staff Writer


Cybersecurity is like a maze that companies in all industries need to navigate to avoid costly security breaches. The challenge is knowing where and how to get started. An FDA official shared some valuable insight on the subject at MedTech Intelligence’s conference on Medical Device Cybersecurity.

Suzanne Schwartz, associate director for science and strategic partnerships at the Center for Devices and Radiological Health (CDRH), talked at length about the FDA’s approach to cybersecurity at the conference held in Washington, D.C., March 23-24. Schwartz referred to medical cybersecurity as an ecosystem, which encompasses every organization involved in designing, manufacturing and using medical devices.

Jul 11, 2017

Developing a Quality System on a Managed Budget

Budget Constraints Constantly Evolve

Through an Organization's Life Cycle


by Keith Matthews


Director, Quality Systems 


Regulatory Compliance Associates Inc.


Insights on driving value from staffing, automation and continuous improvement

Developing a quality system is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction.  Throughout the organization’s lifecycle, from start-up through maturity, the quality needs of the firm, along with its budget constraints, are continually evolving.  Maintaining compliance with regulations while controlling costs represents a challenging balancing act we encounter in our life science consultancy.  The most successful firms apply critical assessment of their needs and gaps at present and in the future, and deploy a risk-based approach to their quality system.

Jul 6, 2017

Why the Supply Chain is So Important Toward Supporting Business Success


Pharmaceutical, healthcare delivery and
food-related supply chains have a
critical and important mission of insuring
agility, resiliency and more timely
and successful business outcomes.

by Bob Ferrari

 

Managing Director, The Ferrari Consulting and Research Group


Founder and Executive Editor, Supply Chain Matters blog


Let me begin this guest commentary hosted on the MasterControl GxP Lifeline blog with a brief introduction to readers.

I term myself as an observer of multi-industry supply chains from respective management practitioner, technology implementer and industry analyst roles. I founded the SupplyChain Matters blog nine years ago to help industry supply chain teams understand the interactions and contributions of the supply chain toward responsive business processes and effective implementation of technology to support ever-changing business needs and requirements. I purposely selected the name of our blog masthead to reinforce to our readers that supply chains, along with their associated people, process and technology capabilities do matter toward supporting positive business outcomes.

Jun 29, 2017

An Exciting Time in Life Sciences: Touching Stories from a Life-Improving Industry

Recent life science developments have yielded
amazing products, including spinal cord stimulation
technology and cochlear implants that restore hearing.

by Marci Crane


MasterControl, Staff Writer


A recent industry outlook for the life sciences industry published by Deloitte mentions opportunities and concerns facing the life sciences industry.1 The concerns—as in former years—include managing costs, getting customers engaged and adjusting to a constantly shifting regulatory environment. The main opportunity identified by Deloitte for life science companies in 2017 is the early use of collaboration with patients and other key players as a risk reduction technique during the research and development and early product planning processes.

After reading the Deloitte report, readers may come away with varying views of the life sciences industry. Those “glass half full” persons will focus on the opportunities named and those more in favor of the “glass half empty” viewpoint will find their attention on the imminent challenges of getting a life sciences product to market. However, regardless of anyone’s focus, it’s apparent from both viewpoints that useful innovation in the life sciences can result in life-saving products, happier lives—and if all goes well—increased revenue.

Jun 27, 2017

Combination Products and CGMPs: What You Should Know

 by Dr. Karl M. Kapp


 Department of Instructional        Technology


 Bloomsburg University


 At the beginning of this year, the FDA    issued final guidance for Current Good  Manufacturing Practice (CGMPs)  Requirements for Combination Products.  This guidance is for therapeutic and  diagnostic products that combine drugs,  devices, and/or biological products. This  guidance has become increasingly  necessary due to the rapid pace of technological advances in the life science industry where product types continue to merge and blur lines of traditional separation.

Jun 22, 2017

Free Webinar: What the New European Med Device Regulation Means

by Cindy Fazzi


Staff Writer



The European Parliament recently adopted a stricter, more extensive Medical Device Regulation (MDR) to replace the Medical Device Directives (MDD). It will affect all manufacturers selling devices in the European Union. What does the new regulation mean for device manufacturers? Will it make life harder and increase costs for them?

“There’s going to be some reclassification and up-classification of products,” said Linda Chatwin, manager of medical regulatory advisory services for North America at Underwriters Laboratories, popularly known as UL (1). “You will need to evaluate your products and whether they still apply under the new classification rules.”

Jun 20, 2017

Required Records of Selected Regulations Under the Food Safety Modernization Act


The Food Safety Modernization Act requires
records be kept for FDA compliance. Yet
compliance is not as simple as ticking
off a checklist.


by Erika Miller


Food Safety Specialist


D.L. Newslow and Associates



The Food Safety Modernization Act, or FSMA (2011), has dominated the conversation in food safety circles for quite some time now. Compliance dates are arriving, and companies are realizing there is a lot to be done to become compliant. Companies that traditionally had little to no contact with the FDA (if everything was going right) are now seeing activity, whether anticipated or not.

Jun 15, 2017

The Quality Metrics Journey

Establishing, maintaining, and interpreting
quality metrics to determine the suitability
of pharmaceutical products has become
a high priority for the FDA. 

by Susan Schniepp


Fellow at Regulatory Compliance Associates Inc.



One of the most discussed and debated topics on today’s pharmaceutical landscape is the issue of quality metrics. Establishing, maintaining, and interpreting quality metrics to determine the suitability of pharmaceutical products has become a high priority for the FDA. To understand the issue of quality metrics it is important to start at the beginning.


Jun 13, 2017

Understanding FDA’s UDI Guidance: The Key to Compliance

UDI mislabeling recall? Not on your watch.


by Beth Pedersen


MasterControl, Staff Writer


The latter half of 2016 saw the second highest number of U.S. medical device recalls since 2000 with 650 medical devices and over 180 million units pulled from the market, according to Stericycle ExpertSOLUTIONS’ 2016 Q4 Recall Index report. The cause of these device recalls? Software problems led the way accounting for 23 percent of all recalls, with product mislabeling following in a close second. While the report doesn’t cite the specific labeling issues implicated in the recalls, it is likely that at least some of them were due to noncompliance with unique device identification (UDI) requirements.

Jun 8, 2017

Training Does Not Stand Alone: the Quest for Training Effectiveness Continues

How do you measure training
effectiveness in your company?


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?

Jun 1, 2017

Why It’s Time to Revisit FDA’s Quality by Design

by Cindy Fazzi


Staff Writer


Patients of Alzheimer’s disease, their families, and health care advocates recently encountered back-to-back disappointments when two clinical trials for Alzheimer’s drugs failed in quick succession. First, Eli Lilly & Co. stopped its late-stage clinical trial for solanezumab, then Merck & Co. ended its clinical trial for verubecestat. Both studies failed to show efficacy.

Such failures—devastating for patients and costly for the sponsors—are not entirely surprising given that only 32 percent of clinical trials reach phase 3, according to a study published in Nature Biotech (1). 

May 30, 2017

When GCP & GMP Meet



Developments on the manufacturing side of the
house can affect the clinicians conducting clinical
studies and must be communicated in a timely manner.

by Laurie Meehan


Social Media Manager


Polaris Compliance Consultants


Developing safe and effective drugs requires a coordinated effort across a diverse set of disciplines. This is easier to observe at some points in the process than at others. Once a product is well into human trials, it can be easy to forget that developments on the manufacturing side of the house can affect the clinicians who are conducting the studies.


Trialed Drug vs. Marketed Drug


Once researchers are satisfied that animal studies show that an Active Pharmaceutical Ingredient (API) is effective and nontoxic at initial doses, there’s an urgency to get it into the clinic and begin human studies as soon as possible. Though the ultimate product may be marketed in one form, a different form may take less time to manufacture, and so would be the form given to human volunteers in earlier clinical trials.

May 25, 2017

How an Electronic Quality Management System Helps With Cybersecurity

by David Jensen

MasterControl, Staff Writer


For medical device manufacturers, technology is a double-edged sword. The technologies that elevate the quality of life for patients can be used by cyber actors to undermine both the manufacturing organization and the products themselves. This means cybersecurity is as much a quality issue as it is a security issue.

Preventing all security threats and attacks is simply not possible. Therefore, the focus needs to shift from prevention to rapid detection, risk analysis and recovery. To further complicate things, cybersecurity is not just about technology. There is a human component involving users’ online activities that companies need to address with cybersecurity polices. This is where an electronic quality management system (EQMS) can be a valuable asset for assisting with your cybersecurity efforts.


May 23, 2017

The 15 Strangest Phobias and Why They Include the Fear of Paper


Phobias are nearly impossible to understand
with the logical mind. What are you afraid of?

by Marci Crane


MasterControl, Staff Writer


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.

On the other hand, it is easy to identify 15 phobias that exist outside the realm of the more common phobias, or those most people have heard about, such as arachnophobia, the fear of spiders; acrophobia, the fear of heights; or even coulrophobia, the fear of clowns, to name just a few.