• CFDA Medical Device Software Regulation Undergoes Major Revision

    14 April, 2016 Beth Pedersen, Marketing Communications, MasterControl

    With so many international regulatory bodies governing different countries and industries, it can be difficult for manufacturers to stay abreast of all of the changing regulatory environments and requirements across the globe. On August 5, 2015, China Food and Drug Administration (CFDA) released its “Principle of technical review of medical device software” (2015 Order No. 50). The principle, which is only available in Chinese, signals a major change for documentation requirements for stand-alone software or software components developed by medical device manufacturers or their development partners.

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  • The Importance of Applying Risk-based Design Control to Process Validation

    18 April, 2016 Lisa Weeks, MasterControl Communications

    In order to have a successful submission for approval of drugs, medical device, biotechnology, supplements, combination product and IVD an organization must have a prolific and structured design process. According to regulators, this process must now include the explicit condition of technical transfer as a formal review step to manufacturing/assembly.

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  • Coming Soon to a Pharma Inspection Near You: The Program Alignment Group (PAG) Plan

    19 April, 2016 Mark Schwartz Of Counsel, Hyman, Phelps & McNamara P.C.

    There have been at least four FDA initiatives, in the works for some time that, in the coming years, will change the way pharmaceutical (and indeed all FDA) inspections are conducted. We think you should know about these initiatives, and how they are likely to affect the way companies prepare for, and deal with, FDA inspections. Today, we are going to discuss the Program Alignment Group (PAG) plan, arguably the least controversial of the four. Over the next few weeks we will discuss the other three programs that are likely to dramatically affect the inspection landscape.

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  • 4 Downton Abbey Characters Who’d Make Great Quality Professionals (and 4 Who’d Be Bloody Awful)

    21 April, 2016 Lisa Weeks, Marketing Communications, MasterControl

    Are you experiencing Downton withdrawal now that the award-winning PBS costume drama is officially over? You’re not alone. Monday morning water cooler banter hasn’t been the same since our friends in the Great House threw the dust shields over the furniture and bid us farewell. If you’re missing your favorite Downton characters, don’t fret. There is probably a Mr. Carson or Lady Mary sitting in the cubicle next to you. After all, several members of the Crawley household, upstairs and down, possess the skills and personality traits needed for a successful career in quality management—others clearly don’t. Warning: Spoilers ahead!

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  • Don’t Trip over These 9 Document Control Pitfalls

    26 April, 2016 Dave Hunter, Product Management Director, MasterControl

    Document control issues are among the most commonly cited observations in FDA Form 483s and warning letters. In the medical device sector alone, document control-related issues represented 10 percent of Form 483 observations and 8 percent of warning letters in 2014(1).

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  • Proposed Legislation Would Create a New Conditional Approval Pathway to Market for Regenerative Medicine Products

    28 April, 2016 Jeffrey K. Shapiro & Charlene Cho Hyman; Phelps & McNamara, P.C.

    In the emerging world of regenerative medicine, there is a stark dichotomy in the level of regulation applied to products derived from human cells and tissues, or what FDA calls “human cells, tissue or cellular and tissue‑based products” (HCT/Ps).

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  • Top 10 Medical Device Inventions Critical to Parenting

    3 May, 2016 Robyn Barnes, Marketing Communications, MasterControl

    I’m a medical device article junkie and I love all those “Top 10” lists that everyone publishes. Recently I saw one entitled “Top 50 Medical Device Inventors of All Time.” Nice article but it had a few flaws. First, most of the inventors were men. Who doesn’t know that necessity is the mother of invention?

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  • Cleanroom Compliance: How to Address Common Challenges in Document Control

    5 May, 2016 Dave Hunter, Product Management Director, MasterControl

    A recent warning letter to a medical device firm shows the importance of proper documentation of cleanroom maintenance procedures and corresponding control of those documents. The FDA noted the company’s failure to establish and maintain written procedures for avoiding contamination of equipment, as well as the incongruity between some of its cleanroom procedures and records of actual practice (1).

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  • Need Help Navigating UDI? FDA Can Help

    10 May, 2016 Compiled from MedTech Intelligence and FDA reports

    Although the unique device identification (UDI) rule was finalized in September 2013, the compliance rollout period will last several years (based on device classification). To help companies as the rule is phased in, FDA has posted five new education modules. You can find these on the CDRH Learn site.

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  • The FDA Just Completed Its Inspection...Now What?

    12 May, 2016 David R. Butcher, Marketing Communications, MasterControl

    Even after an FDA investigator has completed an inspection at your facility, there’s still plenty of work that remains. At the conclusion of an audit, the inspector will hold an exit interview to discuss observations and present significant findings on a Form 483. What do you do next?

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  • Five Reasons Why TMF Training is Important

    17 May, 2016 Sholeh Ehdaivand, President and CEO, LMK Clinical Research Consulting

    Training is a vital component of workplace efficiency especially when it comes to one of the most important deliverables of a clinical trial – the Trial Master File (TMF). Perhaps that’s why, according to a recent article in Forbes magazine, U.S. companies spent over $70 billion on corporate training in 2014, an increase of 15% over the previous year. If you are lucky enough to oversee the TMF, you spend so much time bringing the right employees on board, it only makes sense you would understand the importance of providing them with the proper training to ensure your TMF is always inspection ready.

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  • SOP Revision SWAT-Style

    19 May, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    SOP revision. It falls somewhere between income tax prep and colonoscopy prep on the likability scale. So why would you want to read about it? Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful. Maybe we have.

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  • Accelerate Time-to-Market by Improving Process Validation

    24 May, 2016 James Jardine, Marketing Communications, MasterControl

    Process validation, a general term for critical disciplines such as risk mitigation/management, quality assurance and change management, is something that far too many life science manufacturers only worry about when a product is just about to go to market. That late in the game, though, it can be hard to produce the required and relevant information that has accumulated during years of product development. In a recent article in PharmTech titled “Reducing the Documentation Burden in Process Validation,” Patricia Santos-Serrao, RAC, of MasterControl explains how regulatory agencies define process validation as it pertains to the collection and evaluation of data from the process design stage all the way through to commercial production.

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  • Kaizen Means You Care

    2 June, 2016 Dan Markovitz, Markovitz Consulting

    I’m shepherding this company along its lean journey, and we’ve started by asking people to simply fix what bugs them. We’re not making people sit through lots of classes, we’re not doing 5S, we’re not trying to “move the needle” on the business—we’re just trying to get people to see that the way things were yesterday isn’t the way they have to be today. We want people to know that they have the power to make things better and easier for themselves. We often forget that’s the real first step in establishing a culture of kaizen—just knowing that you’re allowed to improve things.

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  • 2016 Masters Conference in Amsterdam Sheds Inspiring Light on Quality

    7 June, 2016 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.

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  • Revision is Ongoing for ISO 22000 on Food Safety Management

    9 June, 2016 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.

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

    14 June, 2016 Cindy Fazzi, Staff Writer

    “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.

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  • Six Steps to Qualifying Suppliers

    16 June, 2016 by Robert Packard, Packard Consulting

    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.”

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  • What, No Internal Audits?

    21 June, 2016 Dr. Christopher Joseph Devine, President Devine Guidance International

    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.

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

    23 June, 2016 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.

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