April 3, 2018
By David Jensen, Staff Writer, MasterControl
First the bad news. As long as health care-related data remains a valuable commodity, security breaches and data theft will persist. The good news is global regulatory agencies are ramping up their cybersecurity measures in an effort to restore relevance to the “protection” component of protected health information (PHI).
March 29, 2018
By Craig Morgan, Head of Marketing, goBalto
A look at how the changing makeup of the clinical research workforce, with particular attention to the millenial generation, may present future adjustments and opportunities.
March 20, 2018
By Mike Rigert, Staff Writer, MasterControl
The sophistication and value-added benefits of automated, integrated document control management tools available to manufacturers in the life sciences has come a long way since software solutions were introduced in the 1980s on 5 1/4-inch floppy disks.
March 15, 2018
By David Jensen, Staff Writer, MasterControl
I recently attended the 2018 MD&M West conference, Feb. 5 – 7, in Anaheim, California. The three-day event pulled together the medical device industry’s top engineering, design and regulatory compliance experts. This year’s conference covered the most timely and pressing topics, including technology, cybersecurity, design control, digital health and regulatory updates.
When the medical device excise tax was suspended recently, the industry was left with a sense of déjà vu. Between January 2013 and January 2018, the tax was implemented once and frozen twice. How long will this touch-and-go situation continue?
March 8, 2018
By Christine Simmon, Executive Director of the Biosimilars Council, a division of the Association for Accessible Medicines
It is a difficult irony that even as medical breakthroughs and new life-saving and life-extending treatments bring hope to patients and families across the country, it also is getting harder for many to afford these critical medicines. The rapidly rising cost of brand-name biologic medicines, which comprise the vast majority of new therapies in the pipeline, mean they are often inaccessible for America’s patients.
March 8, 2018
By Michelle Lott, Principal and Founder, Lean RAQA
This is the third post in the series, “The Practical Guide to the ISO 13485:2016 Practical Guide” for medical devices. This post explores examples and application provided within Practical Guide for the implementation of a “risk-based approach.”
March 1, 2018
By Beth Harper, President, Clinical Performance Partners
A look at how some of the insights behind improv comedy training can help clinical trial teams develop and improve communication and problem-solving skills. It's no laughing matter.
February 27, 2018
By Christopher Joseph Devine, Ph.D., President, Devine Guidance International
Christopher J. Devine delves into the topic of medical device installation recordkeeping, and why proper documentation of this process is essential to successfully installing medtech and avoiding warning letters and other mishaps.
February 22, 2018
By Tamara Burch-Williams, Professional Services Implementation Manager, MasterControl
Tip: When the change occurs, review the current regulatory submission(s) and note where updates are needed. Even better, create a working or dynamic version of an updated submission.
February 14, 2018
By Tamara Burch-Williams, Professional Services Implementation Manager, MasterControl
Clinical professionals from around the U.S. gathered Jan. 16-18 at the TMF U.S. Summit 2018 in Orlando, Fla., to discuss current clinical study trends and some of the pressing issues relating to trial master file (TMF) management. Three underlying themes were prevalent throughout the 7th annual event.
February 13, 2018
By David Jensen, Staff Writer, MasterControl
Mobile device technology appears to be taking off. Lately, it seems there are more non-phone-call uses for mobile devices than there are lightbulb jokes. The healthcare industry is becoming particularly mobile device heavy. However, in terms of cybersecurity, mobile medical device technology is causing headaches for healthcare organizations.
February 9, 2018
By Jake Walton, Corporate Operations Quality Manager, MasterControl
This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .
February 6, 2018
By Craig Morgan, Head of Marketing, goBalto
A recent analysis by the Manhattan Institute determined that Phase III clinical trials account for 90% or more of the cost of developing an approved drug from laboratory to pharmacy. [1] Given that reliable estimates put the cost of developing, and gaining marketing approval for a new drug, at well over a billion dollars,[2] it’s clear that human trials are pivotal to the pharmaceutical industry scrambling to find ways to reduce costs and speed timelines, while maintaining the quality and efficacy of the research.
February 1, 2018
By Luana Carone, Solutions Consultant, Asia Pacific, MasterControl
It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.
January 30, 2018
By Patricia Santos-Serrao, Director of Product Strategy, MasterControl
A good place to start is to identify the key stakeholders and decision makers in each department. This exercise will show you how close what is on paper is aligned to what is done in practice. Finding out “who is who” in each department will come with an explanation of their activities… pay attention to the overall scheme and coordination that takes and the various approaches, tactics, and means each department uses to accomplish their tasks. You will need this understanding to be effective as a regulatory leader.
January 25, 2018
By Philippe Charbon, President, Apsalys
Since the U.K.’s Medical and Healthcare product Regulatory Agency (MHRA) (1) and the U.S.’s Food and Drug Administration (FDA) (2), published on this subject in 2015 and 2016, respectively, data integrity continues to gain importance as an issue. Some workshop participants wondered if this is simply a new trending topic that will quickly fade. I firmly believe that it is not.
January 23, 2018
By Jake Walton, Corporate Operations Quality Manager, MasterControl
External consulting firms can be used to provide expert help for many of the standard responsibilities that the quality department is tasked with. These external organizations are ready to provide you with the necessary documents to get on your approved supplier list, and can jump into work at various stages. Look for organizations that have specialized experience in the area(s) you are looking for and they can quickly and effectively help.
January 18, 2018
By Sarah Beale, Staff Writer, MasterControl
For nutraceutical companies, recent headlines promising an FDA crackdown on homeopathic products were probably a bit unsettling. Traditionally the FDA hasn't been involved with homeopathy, but this new guidance means that companies will have to become compliant with these six risk-based categories.
January 16, 2018
By Michelle Lott, Principal and Founder, Lean RAQA
This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the first installment, catch up by reading it here. This post explores how the Practical Guide defines “risk-based approach,” varying terminology, and which systems require it.
