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Apr 20, 2017

What Do Food Facility Auditors Really Want? A Practical Guide to Reducing Your Audit Stress Level


Does preparing for your next
audit give you a headache? PDCA
may help reduce your audit stress.

by Bryan Armentrout


CEO, The Food Leadership Group


Third party audits are critically important to food companies. They are the primary tool your customers use to determine if adequate food safety systems are in place. This article covers some of the strategies and tactics you should employ to maximize your chances of a successful audit.

Does this Scenario Sound Familiar?

A big audit is coming up. The plant has been preparing for months and this is the final team meeting before the auditor arrives. At some point during the meeting the plant manager turns to the quality assurance (QA) manager and says, “Are you ready for the audit?” The QA manager swallows hard and responds, “As ready as we are going to be.”


Apr 18, 2017

Human Factors: Why it is Critical in Designing Medical Devices

Human factors helps design out 
the opportunity for human error

by David Jensen

MasterControl Staff Writer


“Most of the time spent wrestling with technologies that don’t quite work yet is just not worth it for end users, however much fun it is for nerds.” 
---Douglas Adams.

This quote hints at the importance of human factors in technology in medical device design and development. Rollin Fairbanks, director, National Center for Human Factors in Healthcare, talked about human factors and its critical role in medical device design at the PDA/FDA Joint Regulatory Conference in Washington D.C., Sept. 12-14, 2016.

Many issues or mishaps involving medical devices can be attributed to human error. However, instead of focusing on discipline, mindfulness and training of end users, Rollin stressed that human error cannot be eliminated, but it can be significantly reduced with the right approach to product design.

Apr 13, 2017

Site Selection: Don’t Forget About the Study Drug

When conducting GCP audits,
many criteria must be checked
including those that affect the
drug you are testing.


by Laurie Meehan


Social Media Manager


Polaris Compliance Consultants, Inc. 



As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and timeframes, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient database and assessing inclusion/exclusion criteria. They’re reviewing staff credentials and ensuring they have adequate resources to manage the number of subject visits and collect the data the protocol requires.

But when we conduct GCP audits, we find there’s one perspective that is sometimes overlooked by both sides: the needs of the study drug itself. 

Apr 11, 2017

Top 5 Takeaways from MedTech Intelligence’s Medical Device Cybersecurity Conference

by David Jensen


MasterControl Staff Writer


I recently attended a conference on Medical Device Cybersecurity hosted by MedTech Intelligence held March 23-24, in Washington, DC. It’s evident that cybersecurity is an important concept as attendance, both in-person and remote, was high. Conference organizers lined up a powerhouse group of presenters who are all entrenched in the technology, cybersecurity, legal and regulatory compliance industries.

For two days, attendees had the opportunity to hear from and converse with officials from FDA, cybersecurity experts from the Mayo Clinic and the Medical Device Innovation Safety and Security (MDISS) Consortium, attorneys specializing in life sciences and healthcare and engineers in medical device manufacturing.

For those of you who were unable to attend this event, here are my top 5 takeaways:

Apr 6, 2017

4 Rules for Building an eClinical Qualification Framework


by Rob Sims


UL Compliance To Performance


Marketing Programs Manager


As clinical trials continue to expand globally, technology plays a critical role in maintaining data integrity and at the same time accelerating study start-up. Consider a study management team that must travel globally to hold investigator meetings. Travel now takes up a much greater portion of the study management team’s time and energy.  That’s why study teams have turned to eClinical technology to reduce this effort – from preclinical R&D and regulatory communication to packaging/distribution and post marketing studies. 

In this clinical ecosystem is also site personnel qualification technology, which must be targeted to each role within the clinical research site. Otherwise, individuals within the site would receive too much or not the right protocol and non-protocol items that align with their role.

Apr 4, 2017

How to Practice Quality Management in Your Personal Life


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. 

I've worked in the quality software business for over 12 years, and I still don't know what to say when someone asks me what I do for a living.

It generally goes like this:

Mar 30, 2017

5 Warning Signs of Diminishing Supplier Quality

Medtech manufacturers who don't know 
what signs to look for will struggle to know
if a supplier's quality system is failing.


by David R. Butcher


MasterControl Staff Writer


Is your supplier’s quality system doing what it’s supposed to be doing? Would you know if it weren’t? How would you know if there were flaws in your supplier’s quality processes before the problems get worse? These are the questions MasterControl’s Terrance Holbrook attempts to answer for medical device manufacturers in a recently published post on MDDI’s Device Talk blog.

“If a manufacturer doesn’t know what signs to look for, it will struggle to know if a supplier’s quality system is failing, let alone keep the results of poor supplier quality from spreading,” according to Holbrook, a senior product manager with 20 years of industry experience in manufacturing and seven years in product development of medical devices.

To anticipate supplier quality issues before problems spread, manufacturers should be mindful of the following five red flags, which should alert you to declining supplier quality.

Mar 27, 2017

When You Find Yourself Between a Rock and a Hard Place


Adventurer Aron Ralston is a survivor
 if there ever was one.


by Beth Pedersen

 

MasterControl Staff Writer


We all have those days where everything that can go wrong, does. Where it seems the entire universe is working against you, testing your patience, your determination and your will to carry on. But in the scheme of things, are these so-called bad days really that bad?

Aron Ralston, an experienced outdoorsman and climber, took the concept of a bad day to a whole new level when he found himself alone and trapped in a remote Utah canyon, his arm pinned by a massive 800-pound boulder. Five days and seven agonizing hours later, Ralston’s extremely bad day had become nothing short of a life-or-death situation. To survive, he was faced with an unthinkable decision, and the ordeal would forever change his perspective on what truly matters in life.
The survivor and best-selling author will share his harrowing experience along with wisdom on how to conquer life’s “boulders” – both big and small – in the keynote address at the 2017 Masters Summit, MasterControl’s largest annual user conference, to be held on Oct. 10 in Salt Lake City.

Mar 23, 2017

FDA Guidance Answers Questions Regarding Data Integrity

FDA is seeing too many 

data integrity-related violations.


by David Jensen


Marketing Communications


MasterControl


An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “Data Integrity and Compliance with cGMP.” The purpose of the guidance is to address some of the frequently asked questions and to clarify the role of data integrity in drug manufacturing.


FDA finds the increase of data integrity violations troubling. Nevertheless, the agency’s current position on the content of the guidance is that it should be viewed only as recommendations. The use of the word “should” in Agency guidances means that something is suggested, but not required.

Mar 21, 2017

The Most Important Four-Letter Words in ISO 9001:2015


If transitioning to the new ISO 9001:2015, 
be very familiar with both four-letter words
emphasized in the document: risk and plan.

by Christine Park


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 …. risk and plan. While these words are emphasized throughout the document, they aren’t new within the business or quality management systems.

Risk-based thinking is something we all do every day and has always been important in business management.  Now that the new ISO standard requires the quality management system to be aligned with business strategy, the use of risk management allows for greater flexibility and less prescription.  Additionally, the use of risk is considered a preventive tool and since it has been integrated throughout the standard, the specific clause for preventive action was eliminated from the standard.

Mar 16, 2017

FDA Eager to be Innovative Partner with Expedited Access Pathway

Expedited Access Pathway: for patients
who have few or no other options.


by David Jensen

Marketing Communications

 
MasterControl



Part of FDA’s prime directive is to assure the safety, effectiveness and quality of biological products and medical devices. So the notion of FDA endorsing the acceleration of product development might raise some eyebrows. However, FDA officials and industry experts alike seem to agree that with some patients waiting is not the hardest part, it’s actually not an option.

Two accelerated manufacturing programs currently in the spotlight are the 21st Century Cures Act and its medical device sibling, the Expedited Access Pathway (EAP) program. Dissenters believe these programs might compel FDA to relax its regulatory oversight in order to fast-track a product’s development and manufacturing. According to Center for Devices and Radiological Health (CDRH) director Jeffrey Shuren, it’s quite the opposite. In an FDA Voice blog post, Shuren summed up EAP as a way to “speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDA’s high standards for safety and effectiveness.”

Mar 14, 2017

The Inner Game of Continuous Improvement

Overcoming anxiety and self-doubt can
help you win in sport and in your career.

by Jon Miller


Co-founder and Partner

Gemba Academy


Five-time Superbowl winner Tom Brady credits reading The Inner Game of Tennis by Tim Gallwey for helping him overcome anxiety and self-doubt, and to keep winning. I read the book looking for parallels and general lessons that could be applied to workplace performance and continuous improvement, and was not disappointed. Here is a summary of what I learned about what I will call “the inner game of continuous improvement.”