Jun 26, 2014
On March 31, 2014, the Chinese State Council unveiled its amended “Regulations for the Supervisions and Administration of Medical Devices,” aka State Council Decree No. 650. The amended decree, which went into effect on June 1, 2014, will be enforced by the U.S. Food and Drug Administration’s counterpart in China, the China Food and Drug Administration (CFDA), formerly known as the State Food and Drug Administration (SFDA). While many industry observers have characterized the CFDA as being unnecessarily complicated and intentionally ambiguous, the modernization of its fourteen-year-old medical device law suggests that Chinese regulators are finally making strides to facilitate the device approval process, while simultaneously cracking down on overpricing and corporate malpractice. In this post, we’ll compare the updated decree to the original and discuss how the new regulations will impact manufacturers hoping to break into China’s lucrative medical device market.
Jun 24, 2014
|A global regulatory strategy calls on strengths |
from many different departments in a company.
Constant communication between departments is a must.
Having and maintaining strong global regulatory strategy and plans can help your business not only stay in compliance but can be an integral part of corporate market growth strategies. How many of us have jumped into a new market before fully understanding the regulatory requirements and the potential impact of those requirements? If you have, you are not alone. Mapping the requirements as part of your strategic planning may help you identify a great new market or help you avoid a costly mistake.
Jun 19, 2014
|At MasterControl, our mission is to provide tools that allow |
quality and compliance professionals do their job - to make
(often life-changing) products available to more people sooner.
MasterControl has grown our reach significantly over the last 10 years—from a small provider of a narrowly focused document control product to one of the largest organizations in the world focused on helping quality and compliance professionals achieve their purpose. I have met with many of the world’s top quality professionals over the past 10 years and I have been amazed by their devotion and commitment. I have recently found myself asking the question: What drives these dedicated people? Why are they so passionate about their jobs? I believe I have found the answer and it has had a strong effect on how I view MasterControl’s mission.
Jun 17, 2014
|Information security deserves full attention |
throughout pharma and life sciences companies
by Jim King, Senior VP of Technical Support & Infrastructure, MasterControl Inc.
Due to the ever-rising position of information as a valuable commodity, organizations must take steps to protect their data. For pharma and life sciences companies, the question is not if their digital data will be compromised, but when. Here are three common security mistakes made by enterprises and ways to avoid those mistakes by focusing on employee behavior.
Jun 12, 2014
|Quality-related issues are one of the most common reasons for|
market entry delay. Where does your product rate on this scale?
In a recent review, I summarized the underlying reasons contributing to delayed market entry for 51 product applications submitted to CDER between 2009 and 2012.1 Reasons cited in the complete response letters issued for these applications covered a number of areas, including safety, efficacy, regulatory, labeling and quality related issues. Quality- related issues were one of the most prominent reasons for delay of market entry with deficiencies being cited in 20/51 (39%) of applications. GMP inspection failures and data deficiencies contributed equally to the quality citations. The prominence of quality-related issues in the delay of product approvals emphasizes the importance of robust quality programs in drug development. Understanding what elements have posed as hurdles in past development programs will help a sponsor avoid these pitfalls in the future.
|MasterControl is a regular exhibitor at MD&M East |
and at the DIA Annual Meeting. Look for us later
this year at Compamed in Dusseldorf, Germany.
Marketing Communications, MasterControl Inc.
June is the month for weddings and trade shows. Though we're not celebrating any nuptials, you’ll find MasterControl at MD&M East this week and at DIA the week of June 15.
“MasterControl is regular exhibitor at MD&M East,” says Jill Bumgardner, MasterControl’s global events manager. “We’ll be in Booth 2421---it’s a great location and easy to find. As easy as anything is to find in the Javits Center,” she adds wryly.
“MD&M East is a good show for us," she continues."We’ll be demonstrating the MD™ Software Suite, which includes document control, training management, CAPA process, and audit and risk management. We’ve had a number of companies pre-register for demos, so we’re expecting a good crowd.”
Jun 10, 2014
|Does your company adequately document the |
actions it takes to ensure quality success?
By David R. Butcher, Marketing Communications, MasterControl
A formal Corrective Action/Preventive Action (CAPA) can be a powerful tool for meeting current regulatory requirements. Done right, the systematic investigation of the root causes of identified problems or identified risks will prevent their occurrence or recurrence. For many companies, however, a crucial obstacle to CAPA success persists: adequate documentation of actions taken to achieve quality success.
Jun 5, 2014
By Lisa Weeks, Marketing Communications, MasterControl Inc.Because the term “medical device” covers a vast range of equipment, from simple tongue depressors to the most sophisticated life-supporting products, the medical device industry is constantly evolving. Trends such as an aging world population, emerging markets, increased regulation, health care provider consolidation, and consumerization are radically transforming the industry as we know it. In this post, we’ll discuss the top five trends shaping this extraordinarily diverse industry and how device manufacturers can navigate these trends.
Jun 3, 2014
by Lisa Weeks, Marketing Communications, MasterControl Inc.
I’m going to date myself with this post, but so be it. At my house, Friday night is movie night, and every week it’s a struggle to find a film that everyone can enjoy; tweens are especially hard to please. This weekend I came across a film I hadn’t seen in years: the ‘80s slapstick comedy, “The Money Pit.” For those of you who haven’t seen the film, it’s about a young professional couple, Walter and Anna, who think they’re getting the deal of lifetime on a spacious suburban mansion. Unfortunately, their dream home turns out to be a total nightmare. As soon as they move in, the house starts failing apart: the front door collapses, the curved staircase caves in, black sludge spews from the faucets the wiring goes kaput…in short, hilarity ensues. What does this have to do with a software upgrade, you ask? We’re getting there…