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April 2012

Christine Park

Surviving the Back Room During an FDA Inspection

by Christine Park
Christine Park & Associates

During one of my early inspection experiences with the FDA, I found myself working with a team that felt it didn't need a backroom setup to review documents prior to bringing them to the investigator. Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.

The investigator requested a specific document which was brought into the room. During the review, the investigator asked to speak to the individual who had signed the document. Unfortunately, there was no one in the room who could identify the signature. Things started to deteriorate quickly from that point on. It was obvious that while team members were able to locate the document, there were issues within the document, creating more questions and concerns from the investigator. I found myself stepping out of the inspection to set up a mini backroom process to screen the documents prior to sending them to the investigator. Granted, if there were errors in documents, there was no time to fix them, but at least we were able to explain and address them.

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Cindy Fazzi

How Life Science Companies Can Leverage Mobile Technology

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

Mobile technology has come a long way. Smartphones and tablets are getting better, smaller, and less expensive. It is no wonder that almost everyone has one.

More and more employees use them not just for personal reasons, but to perform some of their work. In many cases, companies are forced to provide IT support for these employees. Those companies find themselves having to catch up with their employees who are leveraging mobile technology.

What does this mean for you? If you work for a life science company, mobile technology can be very helpful. Mobile devices offer access to information and connectivity to other people, anytime and anywhere. Your team members don't need to be in front of a computer to perform their tasks or participate in compliance processes. This kind of flexibility can greatly enhance team coordination, not to mention increase efficiency.

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Bob Mehta

Employing Audits for Improved Supplier Performance

by Bob Mehta
GMP ISO Expert Services

According to the FDA, 21 CFR Part 820.50 (Purchasing Controls) continues to be a significant concern, with the agency issuing Form 483 Observations and Warning Letters citing continued violations by device manufacturers. According to Kimberly Trautman, the FDA's current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) expert, suppliers providing non-conforming material are directly related to an increase in medical device recalls, which increases the need for effective quality processes to mitigate risk. With the FDA's increased vigilance, how can device manufacturers better position themselves to achieve and sustain compliance? The answer lies in the establishment of an effective purchasing control procedure that places significant emphasis on supplier controls and the establishment of a value-added supplier audit program. A value-added supplier audit program can help organizations mitigate business and regulatory risk while reducing the Cost of Poor Quality (COPQ).

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Patricia Santos-Serrao

Patricia Santos Serrao Quality and Risk Management in Clinical Studies

by Patricia Santos-Serrao
Senior Product Manager, Life Sciences, MasterControl, Inc.

With all that goes into a clinical trial, from documentation and procedures, to a variety of study support staff, managing risk may often be overlooked or merely addressed in a reactive way. However, in order to increase success in clinical trials, an organization must have an efficient risk management plan and be proactive and not simply reactive. In order to obtain a complete understanding of risk in a clinical trial, a risk assessment must be taken from various perspectives. Also, risk management is more than just assessing the risk; it should include contingency plans for rectifying and preventing risk in order to minimize risk.

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MD&M East
May 21-24, 2012, Philadelphia, PA

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Did you know that the term DIY Medical Device might conjure images of a FDA nightmare in the minds of most? "But in a time when healthcare costs are increasing globally, Jose Gomez-Marquez, director of the Director of the IIH (Innovations in International Health) Lab at MIT, has embraced the idea by heading up MIT's Little Devices group, dedicated to design, invention, and policy toward DIY health technologies."
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