GxP Lifeline

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

24 June, 2016 Marci Crane, Localization Manager, MasterControl

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.
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Thermo Fisher Unit Thrives Thanks to Streamlined Document Management

28 June, 2016 James Jardine, Marketing Communications, MasterControl Inc.

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

29 June, 2016 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.”
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Clinical Trial Recruitment Planning: FDA and Others Provide Tips and Tools

5 July, 2016 Mukesh Kumar, Adjunct Assistant Professor, Clinical Research and Leadership at George Washington University

Challenges in recruiting patients are the most common reason for delays and increasing costs of clinical trials. This week (1) the Clinical Trial Transformation Initiative (CTTI), a joint program between FDA, Duke University and industry representatives, announced recommendations for creating robust recruitment plans for clinical trials taking into consideration the most common challenges and potential solutions. CTTI also released a set of four tools to help with the recruitment planning. These recommendations are based on a survey of the most common reasons trials fail to recruit adequate number of participants and suggest actionable solutions.
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From Spectacular to Sensible: How Cost Control is Driving Innovation in the Medical Device Industry

7 July, 2016 Mickey Garcia, Segment Manager, Medical Devices, MasterControl

In the old world, small incremental improvements to medical products could mean big profits if you could get them to market first. In other words, the business drivers in the medical device industry typically included evolutionary innovations in product performance and speed to market. Cost savings rarely, if ever, came into play. However, in today’s brave new health care world, payers are increasingly scrutinizing the precise gains in the outcomes from an improved product.
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What Will Quality Look Like in 20 Years?

12 July, 2016 Peter J. Holtmann, President and CEO, Exemplar Global

To look to the future, the quality profession is revisiting its roots. The question is, “Where is the next generation to help the profession look ahead?” Or, as I like to think of it, “What’s the emoticon for quality?”
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Aligning ISO 13485:2016 With Additional Standards and Regulations

13 July, 2016 Marci Crane, Localization Manager, MasterControl

MedTech Intelligence, a content hub for the medical device industry, provides a continuous stream of new business analysis, technological news, trend summaries, regulations, expert opinions and networking opportunities to medical device professionals. MedTech Intelligence will host the upcoming 13485:2016 conference on July 28-29, 2016 at Dentons, 1900 K Street NW, Washington D.C.
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