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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).