Jul 28, 2017

Good Communication Skills are Key for Inspection Readiness

When an FDA inspector comes to your door, it is usually a time of stress and uncertainty.  You need to handle logistical elements like where the inspectors are going to be placed, how you will gather the requested data and forms, how prepared the facility is and with whom will the inspectors be interacting.

But you must also consider whether or not the personnel in the organization are properly prepared to communicate and interact effectively with the FDA investigator.  You want your personnel to be familiar enough with the processes and procedures of the inspection to provide the best possible impression .  In short, you need to help the quality assurance, auditing and operations teams understand what’s expected during a FDA and/or EU inspection. Of course, the best way to be ready for an inspection is for your company to have your processes, procedures and documentation under control and operating in a state of compliance with regulations.

Jul 25, 2017

Not Just Tiny Humans: Considerations for Conducting Pediatric Clinical Trials

Patient recruitment for pediatric trials
is challenging but very necessary for
drug and medical device development.

by Jamie Arnott, Project Director


Caitlin Hirschman, Clinical Team Lead


When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.

Jul 20, 2017

5 Trends Driving Disruption in the Med Device Industry in 2017

Connected devices for seniors
may allow them to age in place.

by Lisa Weeks

MasterControl Staff Writer

The medical device industry is complex, ever-changing and highly regulated, that much we know. We also know that, despite the complexity, the outlook is rosy for device manufacturers that can recognize—and navigate—the major trends of the day. The purpose of this post is twofold: to identify the trends that are likely to have significant impact on the industry this year, and to provide some high-level tips for exploiting them. Here's a mid-year review of 2017's biggest trends---and some tips for exploiting them.

#1 Other Business Sectors Will Continue to Disrupt the Space

Google and Apple may have led the charge, but we can expect to see other business sectors vying for a piece of the health care market in 2017. “As emerging technologies are further integrated into health care, more tech and non-traditional device companies will continue to enter the space,” according to Matt Lowe, an engineer who has successfully launched more than a dozen medical devices and serves as executive vice president of MasterControl. “To stay competitive, established players will have to gain knowledge of these new technologies, or partner with companies that already have it.” 

Jul 18, 2017

How Training Personnel on Your Quality System Can Produce Positive ROI. Don’t Stop at the Quality Manager.

A company’s ROI from an online training
program can be substantial and immediate!

by Greg Peckford

Founder, Quality Career Advancement

Is the quality manager the only individual within an organization that requires training on quality and improvement methods? Absolutely not! In order for an organization to get the most value out of their quality program, and to ensure it is effective, is to train as many people as possible or even all employees, depending on the size of the company, on the concepts and strategies that its quality management system is based on.

Jul 13, 2017

FDA Favors Collaborative Approach to Medical Device Cybersecurity

Implement cybersecurity at the grassroots
level of medical device development

by David Jensen

MasterControl Staff Writer

Cybersecurity is like a maze that companies in all industries need to navigate to avoid costly security breaches. The challenge is knowing where and how to get started. An FDA official shared some valuable insight on the subject at MedTech Intelligence’s conference on Medical Device Cybersecurity.

Suzanne Schwartz, associate director for science and strategic partnerships at the Center for Devices and Radiological Health (CDRH), talked at length about the FDA’s approach to cybersecurity at the conference held in Washington, D.C., March 23-24. Schwartz referred to medical cybersecurity as an ecosystem, which encompasses every organization involved in designing, manufacturing and using medical devices.

Jul 11, 2017

Developing a Quality System on a Managed Budget

Budget Constraints Constantly Evolve

Through an Organization's Life Cycle

by Keith Matthews

Director, Quality Systems 

Regulatory Compliance Associates Inc.

Insights on driving value from staffing, automation and continuous improvement

Developing a quality system is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction.  Throughout the organization’s lifecycle, from start-up through maturity, the quality needs of the firm, along with its budget constraints, are continually evolving.  Maintaining compliance with regulations while controlling costs represents a challenging balancing act we encounter in our life science consultancy.  The most successful firms apply critical assessment of their needs and gaps at present and in the future, and deploy a risk-based approach to their quality system.

Jul 6, 2017

Why the Supply Chain is So Important Toward Supporting Business Success

Pharmaceutical, healthcare delivery and
food-related supply chains have a
critical and important mission of insuring
agility, resiliency and more timely
and successful business outcomes.

by Bob Ferrari


Managing Director, The Ferrari Consulting and Research Group

Founder and Executive Editor, Supply Chain Matters blog

Let me begin this guest commentary hosted on the MasterControl GxP Lifeline blog with a brief introduction to readers.

I term myself as an observer of multi-industry supply chains from respective management practitioner, technology implementer and industry analyst roles. I founded the SupplyChain Matters blog nine years ago to help industry supply chain teams understand the interactions and contributions of the supply chain toward responsive business processes and effective implementation of technology to support ever-changing business needs and requirements. I purposely selected the name of our blog masthead to reinforce to our readers that supply chains, along with their associated people, process and technology capabilities do matter toward supporting positive business outcomes.