Sep 29, 2016

How to Use Postmarket Surveillance Data to Gain a Competitive Edge

There's a treasure trove of PMS 
data you're probably not using.

By Lisa Weeks, Marketing Communications MasterControl  


Medical device companies are required to conduct postmarket surveillance (PMS) on their devices to maintain high product quality and safety. However, few companies realize the true value of the digital feedback they receive. In this post, we will explore current best practices for collecting and interpreting postmarketing intelligence, and discuss how you can use the information you acquire to gain a competitive advantage.

Sep 27, 2016

Tweet This — If You Want to be Slapped with an FDA Warning Letter

These do's and don'ts will help you
 engage with customers compliantly.


 by Lisa Weeks

 Marketing Communications,      MasterControl



Is the FDA starting to get serious about how medical devices and prescription drugs are being marketed on social media? Many experts think so, citing Kim Kardashian’s highly publicized misleading endorsement of the morning-sickness medication Diclegis® as an example. The offending post, which appeared on the reality star’s personal Instagram page, earned drug maker Duchésnay a warning letter, demanding an immediate retraction. The post was promptly removed—after it had garnered 450,000 likes from Kardashian’s over 42 million followers. 

Sep 23, 2016

Preparing for the Impending Medical Device Regulation

The Medical Device Directive (MDD) 
is being recast as the Medical 
Device Regulation.  It's time to 
learn some new rules.

by Linda Chatwin, Esq, RACUL, LLC Senior Customer Solutions Consultant


It’s coming – and at this point, nothing will stop it. The Medical Device Directive (MDD) is being recast to a regulation – the Medical Device Regulation (MDR). It has been over four years in the making and the EU countries have spent many hours (actually over four years) working to agree on its Consolidated Negotiated Text.

Since the MDR is now a regulation as opposed to a directive, the member states in the EU are bound to abide to it – giving it strength equivalent to the FDA’s CDRH regulations in the US. The EU is the world’s second-largest medical device economic area/region, and the regulation, felt to be long overdue, will regulate devices not only manufactured and marketed within the EU, but also devices that will be imported into the EU.  The regulation includes rules for determining device classification, requirements for quality systems, obtaining pre-market authorization, and monitoring device performance in the field, including reporting of adverse events.

Sep 20, 2016

Identifying and Preventing Common Data Integrity Issues

Data integrity is important to the 
quality control laboratory because poor
practices can allow for substandard 
product to reach patients.


by Joanna Gallant

Owner/President, JGTA, LLC

Because of the multitude of problems being found in regulatory agency inspections, data integrity is a hot issue for regulators around the world today.  Data integrity is critically important to regulators for a variety of reasons, including patient safety, process and product quality.  The integrity and trustworthiness of the data provides a baseline for the regulators opinion of the personnel and the company as a whole.
Data integrity is of particular interest in relation to the quality control laboratory and the handling of OOS results, because poor practices can allow for substandard product to be put into the hands of patients.  But the same holds true for any other area that generates or controls data – including IT, R&D, manufacturing – any data integrity failures from these areas can also impact patient safety, product and process quality effects.

Sep 15, 2016

Is Compliance an Obstacle to Quality?

The FDA is shifting from a primary focus on 
regulatory compliance to driving the industry 
beyond compliance by focusing on product quality.


by Daniel Matlis

Founder and President, Axendia


Editor’s Note:  Recent news about FDA’s Quality Metrics initiative triggered an “I told you so” moment: Is Compliance an Obstacle to Quality? Axendia wrote this article over two years ago in Life-Science Panorama (http://axendia.com/blog/2014/04/14/is-compliance-an-obstacle-to-quality/ ).  It’s as true today as it was then.

Can you distribute poor quality products while complying with regulatory requirements?  Sure, after all, you can conduct a recall of poor quality products in compliance with all applicable regulations.

Regulatory compliance and quality are NOT the same.  In fact, the industry’s hyper-focus on compliance is often an obstacle to quality.

Sep 13, 2016

"Hacking" Quality


Can quality be "hacked?"  Do Deming's 
tenets of quality still stand or  
is it time modify them?


by Peter Holtmann

President & CEO

Exemplar Global Inc.


Continuing my theme of the future of quality, the ability to see the future could come through some interesting lenses—hacking, for instance.

Hack:

A clever solution to a tricky problem.

To hack is to modify or change something in an extraordinary way. (Urban Dictionary)

While a more traditional definition of hack may be along the lines of roughly cutting away at something, the younger generation’s perspective of hack, as defined above, describes how the term serves their lifestyle.

Sep 6, 2016

Free E-Book Depicts a Decade of Change in Life Science Regulatory Compliance

This enhanced e-book describes the 
changing regulatory landscape and 
what life science companies can 
expect in the future.


Cindy Fazzi

Editor, MasterControl Insider


Which came first, the chicken or the egg? This dilemma applies to automation and regulatory compliance. Did the FDA issue 21 CFR Part 11 to encourage technology use? Or did life science companies use technology first—prompting the FDA to develop corresponding regulations?

The chicken-or-egg riddle may never be answered, but a new book, “Convergence of Compliance and Technology,” traces key developments in the past 15 years that revolutionized regulatory compliance for the life science industry.

Scientific breakthroughs—such as a drug that treats cystic fibrosis and a brain sensor to help paralyzed patients control assistive devices with their thoughts—are possible only with the help of faster and more efficient, technology-driven clinical trials, regulatory submissions, and approval process (1).

Sep 1, 2016

Labor Day by the Numbers: Life Sciences & STEM Edition

As we prepare to celebrate Labor Day this weekend,
 browse some fast facts about the nation's
 life science workforce,


by David R. Butcher

Marketing Communications, MasterControl


Did you know that science, technology, engineering and mathematics (STEM) job opportunities in the United States are expected to grow 17 percent by 2018? Or that 39 percent of hiring managers believe science and clinical workers are in short supply?

The annual celebration of workers’ contributions and achievements in the U.S. is right around the corner. As we welcome Labor Day and say farewell to summer – hopefully enjoying the long holiday weekend free of work duties – peruse some interesting facts and figures pertaining to the many hardworking professionals in the life science industry and the STEM fields.



Aug 30, 2016

UDI: When the Rule is Not Enough


FDA recently issued a draft guidance 
on the form and content of the UDI.

by Jennifer D. Newberger

Hyman, Phelps & McNamara, P.C


With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content of the UDI. More specifically, the draft guidance states that its intent is to “clarify” for industry and FDA-accredited issuing agencies the form and content of the UDI, and to “better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with” the UDI rule.

Aug 25, 2016

10 Things I Wish I’d Known Before Writing my FDA Response Letter

Don't bury your head in the sand; 
start your response letter ASAP

by Alex Butler

Medical Device Segment Manager, MasterControl 


If you’ve ever received a 483 or warning letter, as I have, you know the chaos that can ensue. The clock is ticking; the FDA requires a response to most compliance notices within 15 business days!

I received a warning letter while working for a leading global manufacturer of dental materials, devices, and instruments. As part of the remediation team assigned to address the citation, which entailed overhauling the company’s entire quality system, I understand that time is of the essence when crafting a response letter and remediation plan. Working many nights and weekends, it took my team eight months to receive our close-out letter, then we spent another year implementing our remediation plan—all while performing our “regular jobs.” It was a grueling process, but I learned a few remediation lifehacks that may save you time and frustration.

Aug 23, 2016

If Taylor Swift Were Your FDA Auditor or How to Present Yourself and Your Company During an FDA Audit

Would you pass or fail if 
Taylor Swift audited your company?

by Marci Crane

Localization Manager

MasterControl


Note to the reader: If you’re one of the few Americans or “Planet Earthians” who has not yet heard the sweet stylings of Miss Taylor Swift blasted enthusiastically by excited millennials, then the Taylor humor in this article may not make a whole lot of sense. However, it is still worth reading. After all, you wouldn’t want to be caught off guard if an FDA auditor were to say:

“Saw you there and I thought/ Oh my God, look at that face/ You look like my next mistake.” – "Blank Space"

The current data show that an adult is likely to change employment at least a few times during his or her lifetime. Taylor Swift, on the contrary, is one of the rare individuals who most likely will never have to remake her career. However, surprises do happen, and would it be so far-fetched to imagine that at some point in the near future Taylor might take up auditing? And not just any auditing, but auditing for the FDA?

Aug 19, 2016

Mayday! Mayday! These "Unknown Unknowns" Can Torpedo Your QMS

Are knowledge gaps leading your 
quality efforts off course?


by Walt Murray, CLA, CSSMBB

ARC Experts



In psychology, people talk about knowledge and learning in terms of four levels: what we know, what we think we know, what we know we don’t know, and what we don’t know we don’t know. In the life sciences, the fourth level, what we don’t know we don’t know (or unknown unknowns, for short), carries the most risk in quality and compliance.