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Dec 30, 2014

Stedman Graham Steps Out of Oprah’s Shadow, Shares Secret to His Success

Stedman Graham Steps Out of Oprah’s Shadow, Shares Secret to His Success
Stedman Graham shared his nine-step plan for 
success at MasterControl's Masters Summit.
by Cindy Fazzi
Editor, MasterControl Insider

Stedman Graham, CEO of S. Graham and Associates and a best-selling author of motivational books, shared the secret to his success. No, it’s not Oprah, though he’s widely known for his long-time relationship with one of the world’s most famous media personalities. 

During his keynote speech at the Masters Summit, MasterControl’s premier educational conference for customers, Graham said, “When I think of MasterControl, I think of leadership.”(1) He posed a challenge to the standing-room-only crowd: “Can you be the master of your own development? Can you master your own life? Can you co-create with the world?”

Dec 23, 2014

Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

FDA issued a new draft guidance in 2013 on 
the biological evaluation of medical devices.
by Cheryl Wagoner
Principal Consultant/Owner
Wagoner Consulting LLC

As part of FDA’s efforts to harmonize their requirements with those around the world, it has issued a number of guidance documents to help explain the agency’s position, especially in cases where FDA has some variance with a given international standard.  The current FDA guidance regarding biological evaluation of medical devices, Blue Book Memo #G95-1, was issued July 1, 1995 and replaced the FDA Tripartite Biocompatibility Guidance #G87-1 (April 24, 1987).  On April 23, 2013, FDA issued a new draft guidance entitled “Use of the International Standard ISO-10993 BiologicalEvaluation of Medical Devices Part 1: Evaluation and Testing”.  This guidance has much in common with the current Blue Book Memo, but expands the details in a number of areas especially regarding the test matrix and the level of detail regarding each test.

Dec 18, 2014

Basics: Documenting a Real QMS

Basics: Documenting a Real QMS

Plan/Do/Check/Act (PDCA) applies to real life
processes and systems,
 
not to systems of documents
panderingto the requirements of ISO 9001.

by T. Dan Nelson
Consultant


Using ISO  parlance, a management system is designed to achieve objectives.   In the case of a quality management system (QMS), the most basic objective is to succeed by satisfying customers.  A QMS is a system designed to satisfy customers by providing them with timely, quality products and services.

A QMS is composed of processes impacting an organization’s ability to fulfill customer requirements.  Two types of processes  compose a QMS: core processes (or primary, realization, or operational processes) and support processes.  Core processes. in a sense, define what an organization does for a living, while support processes are in place to help assure the effective, efficient operation of the core processes (like a training process).

Dec 16, 2014

FDA New Guidance on Informed Consent: Updates to Required Elements


by Paul Cobb
Clinical Research Associate, IMARC Inc.

In July, 2014, FDA released a new draft guidance to reflect current thinking on the informed consent process:  Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.   
While the new guidance is, in many ways, an expansion of current practices, there are several aspects that are noteworthy. It’s important to consider the evolution of FDA thinking regarding Code of Federal Regulations (CFR) required elements of informed consent. (21 CFR 50.25)

Dec 11, 2014

How to Address the Top 3 Supplier Management Issues


How to Address the Top 3 Supplier Management Issues
Do you spend time juggling your suppliers? 
Your suppliers should have the systems in place 
for satisfying your quality and regulatory needs. 

by Matthew M. Lowe
Executive Vice President, MasterControl Inc.


Medical device manufacturers rely on suppliers for many things. Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency—in terms of time, cost, and quality. Unfortunately, suppliers can also sometimes put their clients in hot water when their quality standards are below par.

There are a lot of contract manufacturers that are shifting their focus to medical technology due to the stability of the marketplace as compared with the automotive or aerospace industry. While many of them have good intentions, they often don’t understand the complexities of med tech manufacturing.  

Dec 9, 2014

Five Common Issues that could Jeopardize Training Compliance


Editor, MasterControl Insider

If your company is regulated, then you know that it’s not enough to have your quality standards on paper. You have to implement and integrate them into your daily operations and prove to regulators that your standards and policies work.

“Training is what helps turn the theory of quality into reality,” said Dave Hunter, product management director at MasterControl (1). “Effective training should be a fundamental part of a company’s quality management strategy as it can help prevent many quality problems from ever occurring.”

Dec 4, 2014

Two Keys to Prosperous B2B Customer Partnerships

Two Keys to Prosperous B2B Customer Partnerships
Extraordinary quality management begins with
 remarkable people working together to generate an 
atmosphere that stimulates customer success.
by James Jardine
Marketing Communications

Give the customer what they want. It may be a trite and simplistic aphorism, but it’s one that’s hard to live by in a competitive business world. Yet the companies that stay true to it are always the most successful. That’s because a company that provides products and services to other businesses is only as valuable as the value it supplies. Think of it this way: ‘why’ a company does what it does is even more important than ‘how’ the company does it or ‘what’ it is actually doing.

To create value in the (often highly regulated) realm of quality management systems, one software and services provider has made remarkable strides by concentrating on two core values: customer success and exceptional people.

Dec 2, 2014

A Bipartisan Success at Getting Drugs to the Pharmacy Faster (and Cheaper)



U.S. Food and Drug Administration

Most medications used to be expensive – much more expensive than they are today. As recently as the early 1980s, most important drugs on the market were brand names under patent protection. Generics were uncommon; the cost of developing and marketing them in competition with the big brands was too high. Without change, the relative ease with which most of us get and use prescription drugs today might have been quite different.

Change came in the form of the Hatch-Waxman Act, the law – its 30th anniversary is this year – that established the modern system of generic drug regulation in the United States.  Its original sponsors, Rep. Henry Waxman (D., Calif.) and Sen. Orrin Hatch (R., Utah) brokered a critical bipartisan compromise to ensure the bill’s passage.