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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.

May 18, 2017

Keeping Up with the Top Pharma Industry Trends of 2017


The pharmaceutical industry has realized steady worldwide revenue growth over the past 15 years[i], but there is an array of impending technological, regulatory, socioeconomic, and political changes on the horizon that may significantly impact pharma companies’ bottom lines. In a new white paper titled “Five Pharma Trends that Will Have the Biggest Impact in 2017,” Patricia Santos-Serrao, RAC, MasterControl’s director of clinical and regulatory solutions for pharmaceutical, blood, and biologics industries, outlined the most critical issues affecting the pharmaceutical industry in 2017. The following are several of the exigencies she points to as this year’s major pharma forces.


May 16, 2017

The “New Normal” for FDA Enforcement of the Food Industry: What You Need to Know and How to Prepare

The food enforcement world is changing, and companies need
 to understand four key developments and how to get ahead of them.

by Maile Gradison Hermida


and Brian D. Eyink


Hogan Lovells US LLP


With the parade of headlines announcing a new food-borne illness investigation, recall, or Food and Drug Administration (FDA) enforcement action continuing unabated, food company executives, quality assurance officers, and legal counsel are struggling to understand the new food enforcement paradigm.  Although every situation and company is different, in this article we identify four key developments that all food companies need to be aware of, as well as key steps that will help to prepare for this “new normal” in FDA enforcement.

May 12, 2017

What is a Document Control System?

How to get control of your 

document control system


by David Jensen


MasterControl Staff Writer



Being in the regulated manufacturer arena, you have heard that oft recited phrase “if it isn’t documented, it didn’t happen.” This motto shared among life sciences companies means an efficient document control system is at the core of quality management. Documents and records serve as proof that your company follows good manufacturing and document management practices required for compliance.

SOPs, calibration instructions, procedures, packaging and storage instructions, test plans and validation checklists are just a few of the documents you create and use during a product’s development lifecycle. When the product is on the market, you add in manufacturing history records, change orders, complaints and corrective action reports.

May 9, 2017

What is a Document Management System and 8 Reasons Your Company Probably Needs One

Piles of files or an electronic document 
management solution:  which 
would you choose?

by Marci Crane

Staff Writer


A document management system is a software solution that allows for the digital management of documentation. Today most documentation managed by document management systems is business-related.


What Do Document Management Systems Do?

Document management systems:
  •       Allow for the input of scanned hard-copy paper files into a secured storage
  •       Store documents in one or more secure locations (levels of security vary based on the system itself and on client’s industry and specific needs)
  •       Automatically route documentation to approved users (routes are based on business processes) 
  •       May track all versions of each document in the system (often requires version control capabilities as well as time-stamping technology)
  •       Provide search capabilities (the level of sophistication with the internal search engine of a document management system varies based on the system’s intended design)
  •       May provide a form of validation for regulated industries (for example, for the life science industries, document management systems can assist in demonstrating compliance with FDA requirements and additional international standards.)

May 4, 2017

Life Science Polls Reveal Lack of Automation, High Cost of Quality Stoppages



by Cindy Fazzi

MasterControl Staff Writer


Increased automation through digital technology platforms is one of the top business trends for 2017 (1). It’s a crucial enabler for businesses to compete successfully, according to the IT research and advisory company Gartner Inc.

In the field of quality management, it seems the forecast remains unheeded. A report based on informal polls by MasterControl reveals that the majority (59 percent) still don’t use an electronic system to manage audit and quality processes. The polls also showed that quality issues resulting in stoppages were costly, with 27 percent saying their companies spend between $100,000 and $1 million due to quality-related interruptions.

“I was surprised how many companies don’t have an automated system,” said Curt Porritt, MasterControl senior vice president of marketing. “I was also surprised how much time and money can be lost due to quality issues.”

May 2, 2017

10 Criteria to Aid in the Selection of Investigative Sites

Site selection is pivotal to the successful 
execution of trials. Choose high performing 
sites that are ideally suited to running 
the study under investigation.

by Craig Morgan


Head of Marketing 

goBalto


Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of trials, which are not only long and bureaucratic, but are also experiencing diminishing returns. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market, with daily revenue losses in ranging from $1M to $8M due to delayed market entry.

Key to reining in budget overruns and delays, often fueling the growing rescue studies industry, is the selection of high performing sites that are ideally suited to running the study under investigation. The selection process is, however, often manual, cumbersome and error prone.

The numbers tell a sobering tale.

Apr 27, 2017

"We're Different!" Overcoming the Challenges of Applying Lean Principles to Knowledge Work



Lean process improvement techniques 
can be applied to knowledge work and
knowledge workers.

by Drew Locher

 

President

 

Change Management Associates


If you are applying lean management principles to R and D, life science, or other knowledge work processes, you’ve probably heard the "we're different” argument. It usually goes something like this, “You can’t apply lean process improvement techniques to creative work because everything we do varies."

Knowledge work and knowledge workers are different. But that doesn't mean process improvement concepts don’t apply. It does mean we have to adapt the concepts and approaches by practicing these proven techniques.

Apr 24, 2017

20 Years Later, 21 CFR Part 11 is More Relevant than Ever


by Cindy Fazzi


Staff Writer, MasterControl


If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

First off, what’s new with Part 11? Every now and then, there are rumors about updates. The on-again, off-again speculation stems from the FDA’s “Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application.”

The 2003 guidance says: “While the re-examination of Part 11 is underway, we intend to exercise enforcement discretion with respect to certain Part 11 requirements” (1). And yet, neither re-examination nor update is apparent.

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.”

Mar 9, 2017

Brave New World: The Mutual Recognition of CGMP Inspections


The United States and the European Union
 have agreed to to recognize inspection
 of each other's drug manufacturing facilities.

by Mark I. Schwartz 

Director

Hyman, Phelps & McNamara PC


Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see here and here) amends the Pharmaceutical Annex to the 1998 U.S. – E.U. Mutual Recognition Agreement, with a view to avoiding duplicative inspections and saving millions of dollars in repetitive inspections.

FDA has stated that they believe this “…initiative will result in greater efficiencies for both regulatory systems and provide a more practical means to oversee the large number of drug manufacturing facilities outside of the U.S. and EU.”