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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.