Jun 29, 2016

MasterControl's Murray Defines Risk---and What It Isn't

by Marci Crane

Localization Manager, MasterControl

For medical manufacturing professionals, the MD&M conferences and exhibits are some of the most valuable professional networking tools available. At MD&M East, medical manufacturing professionals, from the eastern United States and from areas spread across the world, meet together with regulatory, quality, compliance, and manufacturing experts to glean and share knowledge. Tracks covered over the course of the most recent conference, held June 13.-15, 2016, focused on “Market Value and Consumer Health, New Technologies, Big Data, and Mobile Product Risk.”

One of MasterControl’s most seasoned quality experts, Walt Murray, presented at the recent conference on risk management, which for the last two years has been an especially salient topic for medical device and medical manufacturing professionals. Between changes in the ISO 13485 regulations and the general management and coordination of regulations and standards across the medical manufacturing industry, risk management is changing in distinct ways that are affecting the medical device and manufacturing sectors.

Jun 28, 2016

Thermo Fisher Unit Thrives Thanks to Streamlined Document Management

Call it the curse of success: as Unity Lab Services—a business unit of Thermo Fisher—flourished, the already massive amount of vital documentation that required tracking, continual updating and maintenance became exponentially larger and more difficult to manage. For a company that has obtained its leading edge by providing customers with a single source for integrated lab services, support and supply management, the very notion of out-of-control documents and outdated, rogue work instructions spelled potential disaster.

In a recently released case study, John C. Brown, MCSE, Senior Systems Administrator at Thermo Fisher Scientific, explained how his organization dumped its obsolete and inadequate document control system in order to resolve its document control dilemma. “We had a highly customized system,” Brown said, “but it was no longer supported by our IT group.”

Jun 24, 2016

MasterControl’s Walt Murray Emphasizes “Establishing Design Parameters” at INTERPHEX 2016

A Retrospective Review of the Successes 

from Interphex 2016 and its Contributors.

by Marci Crane

Localization Manager


INTERPHEX, one of the largest trade shows and combined fairs and exhibitions for the pharmaceutical, biosciences, biotechnology, medical device, and biomedical engineering industries was held last March at the Javits Center in New York, New York. There are 10,000 participants expected every year for INTERPHEX and 2016 was no exception.

“INTERPHEX 2016 was a resounding success for both exhibitors and attendees alike who hailed from 52 countries around the world and 48 states across the U.S.,” said Ed Several, Senior Vice President, INTERPHEX. “This year’s INTERPHEX once again succeeded in bringing together inspired professionals with key industry leaders to share knowledge and best practices, as well as see the latest cutting-edge technologies needed to cost-effectively develop and manufacture quality products.”

Jun 23, 2016

The First Step To Navigating Your Combination Product's Regulatory Pathway: PMOA

A combination product 's regulatory 
pathway can go through one of three 
primary review jurisdictions.

by Winston Brown, 

VP of Global Quality & Regulatory Affairs Phillips-Medisize

The drug-device combination product market is growing at a rapid pace. By 2019, it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012.(1) This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained. To avoid unnecessary delays and gain speed to market through ‘right the first time’ regulatory submissions for a combination product, sponsor companies must understand the various pathways for which a combination product can travel. In addition, companies must also understand their own products enough to be able to discern what specific regulatory path it would follow. This not only preserves the relationship between sponsors and regulators, but it also ensures safe and effective medical treatments reach patients in a timely manner.

Jun 21, 2016

What, No Internal Audits?

An established auditing program
 is a fundamental requirement of a 
quality management system (QMS).

by Dr. Christopher Joseph Devine

Devine Guidance International

Although results don’t need to be shared with FDA during an inspection, an audit still should be performed.

For the aerospace, defense, automotive, pharmaceutical or medical device industries, it really makes no difference when it comes to auditing the effectiveness of the quality management system (QMS): An established auditing program is a fundamental requirement. ISO 9001, ISO 13485, AS 9100, and the primary topic of most of Dr. D’s rants 21 CFR, Part 820 compliance, all have elements mandating that quality audits be performed. So the doctor always finds it quite disturbing when a device establishment fails to comprehend the importance of creating an audit schedule and actually performing the audits.

Jun 16, 2016

Six Steps to Qualifying Suppliers

Do you qualify your suppliers? 
What process do you use?

by Robert Packard

Packard Consulting

Republished with permission

Imagine that you are a QA consultant. Last night you wrote a blog about the three tools needed to qualify suppliers. Today you are auditing a supplier, and have just complimented the purchasing manager on his quality program. During lunch, Kim, the general manager, says, “Michael was just showing me the blog you wrote about how to qualify suppliers. I was confused—your blog seemed to say that we are doing everything wrong, but you just told us that our supplier quality program looks great.”

Your response to Kim is, “The blog you read was describing what your customers should be doing to qualify suppliers—not what you should be doing to qualify suppliers. In your case, most of your suppliers are customer-mandated.”

Jun 14, 2016

The Dude Abides! 5 Quotes from “The Big Lebowski” that Apply to Quality

by Cindy Fazzi

Editor, MasterControl Insider

“The Big Lebowski” never fails to make me laugh. The 1998 cult classic, starring the indefatigable Jeff Bridges, features some of the most quotable lines in film. Saying them is enough to break the ice among strangers at a party. In my family, the quotes are inside jokes that never grow old.

The film is about Jeffrey “the Dude” Lebowski, an unemployed stoner who loves bowling, and his mix-up with an old rich man who shares his name. Played to perfection by Bridges, the Dude is plunged into a misadventure after some baddies who mistake him for his namesake, take the rug in his living room and manhandle him. The rest of the movie is about the Dude’s quest to take his rug—and his peace—back. Along the way, he meets the real “Big Lebowski” (his rich namesake); he serves as the middleman in paying the ransom for the old man’s young wife; and he even romances the man’s estranged daughter, Maude.

Jun 9, 2016

Revision is Ongoing for ISO 22000 on Food Safety Management

by Sandrine Tranchard

Communication Officer for the International Organization for Standardization 

The consequences of unsafe food can be devastating, both for consumers and businesses worldwide. With many of today’s food products repeatedly travelling across national boundaries, ISO 22000 is more essential than ever to the safety of the global food supply chain. Now the standard is being substantially revised to ensure it stays relevant to modern needs. 

Jun 7, 2016

2016 Masters Conference in Amsterdam Sheds Inspiring Light on Quality

The MasterControl user community 
exchanged knowledge and experiences 
at the annual Masters Conference.

by Beth Pedersen

Marketing Communications, MasterControl

Quality, regulatory, IT and management professionals across pharmaceutical, medical device, biotech and manufacturing came together for two days of learning and networking last month in the friendly host city of Amsterdam. Now in its sixth year, MasterControl’s annual Masters Conference, held 11-12 May, offered the user community in Europe a chance to rub shoulders with industry experts, exchange knowledge and experiences with others in the same profession, and receive one-on-one consulting from the MasterControl team. From humorous to emotional and everything in between, the wide variety of presentation topics showed just how diverse and impactful the field of quality can be.

Jun 2, 2016

Kaizen Means You Care

Coworkers Jose and Peter took 
the first step on the road to kaizen.

by Dan Markovitz

Markovitz Consulting

Peter is a 63 year-old man who operates the punch press at his company. At the end of the day, he drags a 50 pound garbage can through the building and out to the dumpster, a distance of about 75 yards.

His colleague, José, is about twenty years younger. Peter and José have been working together for years. Whenever possible, José tries to take out the trash because he doesn’t want Peter to hurt his back—but work being what it is, that doesn’t always happen.