Dec 31, 2015

Big Changes for ICH GCP & EU Regulations

Changes are being proposed for international 
clinical research, including the European Union.  
How and when will they affect your work?

by Laurie Meehan

Social Media Manager

Polaris Compliance Consultants

What GCP changes are being proposed for international clinical research?

How and when will they affect you?

Dec 29, 2015

5 Lessons I Learned from a Successful ISO 9001:2015 Certification Audit

Effective risk management requires an 
in-depth and sometimes painfully honest assessment 
of your processes and your areas of risk. 
by Lillian Erickson
Global Quality Manager, MasterControl Inc.

The publication of ISO 9001:2015 in September generated much anxiety among companies fearing a bumpy transition to the new and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.

Despite having quality experts involved with the ISO changes since they were proposed some years ago, even we did not know how our ISO assessors would apply the new requirements, what evidence they would expect to see, and how to pre-emptively satisfy their expectations.

Additionally, MasterControl is not a typical manufacturer of materials, but rather of software and services. This means we needed to understand the intent of each requirement under the new standard in order to correctly apply them to our products and services.
After much research and preparation, we’re proud of the fact that when we completed the audit successfully on Nov. 12, 2015, no other company in the world had yet received a certificate for the new ISO 9001:2015 standard (1), though a few held audits the same week we did. In fact, it was only that very week that ISO assessors across the globe were authorized by their governing bodies to begin certifying companies to the revised standard.
Some people have asked me what I learned from the audit experience, as well as the preparation that preceded it. Below are five lessons I learned, but first, a quick background.

Dec 23, 2015

A Season for Giving That Lasts All Year

During the holidays and all year round, a gift
by Beth Pedersen, Marketing Communications Specialist, MasterControl

We all feel it this time of year. As temperatures drop and snowflakes swirl, lights and festive decorations illuminate the long, dark nights, and names are diligently checked off seemingly endless shopping lists, we know that the holiday season is upon us. In spite of the stress that can accompany the holidays – the long lines, the gift wrapping, the social obligations – this time of year marks a widespread urge to give: to family, to friends, even to those we’ve never even met. We all feel it, this intangible, albeit very real, spirit of giving.
For many, the spirit of giving carries over into the workplace. When I look at companies in the pharmaceutical, medical device and blood and biologics industries, I am struck by what seems to be a collective tendency toward philanthropy and (at the risk of sounding cliché) a desire to make the world a better place. I can’t help but wonder if the people employed in these industries share some common trait that compels them to help others, both in their private lives and through what they do for a living. Although social responsibility is a year-round endeavor for many organizations, I thought it appropriate to take a moment during the holiday season to highlight one such company and its culture of giving.

Dec 22, 2015

Using Quality by Design to Improve Manufacturing

Process control and process improvement 
are important parts of life cycle management.

by Ronald D. Snee, PhD

Snee Associates, LLC                                                                                                       

Much of the literature on quality by design (QbD) has focused on the creation of the “Design Space” (ICH 2009) which is the combination of levels of the critical process parameters that produces in-specification product. Design space creation is critical but a process control strategy is also essential and is an integral part of QbD. Stage 3 of  the FDA Process Validation Guidance calls for “Continued Process Verification” (CPV),  or continually verifying the process is doing what it is supposed to do throughout the life of the product (FDA 2011, Snee 2015). Also if we are to be effective in using life cycle management to manage the process over time. we must have a process management system in place that integrates both process control and process improvement (Snee and Gardner 2008, Snee 2010b).

The focus on QbD places an even greater emphasis on the quality of pharmaceutical products and manufacturing process performance. Indeed process and product control is a major building block of QbD (Snee 2009). A systematic approach to achieve this objective is described below.  Improved manufacturing performance and reduced costs are a natural byproduct of the system.

Dec 17, 2015

Preparing for ISO 13485:2016 Changes

by James Jardine, Marketing Communications, MasterControl

As 2015 comes to a close, medical device manufacturers throughout the world share one collective concern: how will the ISO 13485:2016 revision compare with other versions of the standard? In a new three-part video series, Walt Murray, MasterControl’s director of Quality and Compliance Consulting (QCC) services, walks through what, why, when and how changes are coming to the standard.

The first video in the series is available here.

Dec 15, 2015

6 Lessons that Quality Managers Can Learn from ‘Star Wars’

by David R. Butcher

Marketing Communications, MasterControl

Beginning with A New Hope nearly 40 years ago, characters in the epic Star Wars saga have offered many lessons that may prove valuable for even the most seasoned quality managers. There are numerous examples of positive behaviors that managers might consider emulating in their daily work and behaviors that should always be avoided.

With the seventh installment in the film franchise arriving in theaters on Dec. 18, here we revisit the series and highlight six lessons that quality managers can learn from a galaxy far, far away.

Dec 9, 2015

The Drug Supply Chain Security Act: Current Impact

The Drug Supply Chain Security Act is the most 
complex pharma track and trace law ever passed.

by David Dills

Sr. Consultant, Regulatory & Compliance, Devices


On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013  (DQSA) into law, bringing a successful conclusion to efforts by the industry and consumer groups to create a national pharmaceutical serialization and track and trace regulation, one that eliminated the patchwork of state laws in addition to providing new regulations for compounding pharmacies.  This is the most complex pharma track and trace law ever passed.

The Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA, is the most complex pharma track and trace law every enacted.  Its many layers of complicated rules and regulations provide challenges that companies will need to untangle indeed. 

Dec 7, 2015

How Performance Excellence Helps Broaden the Horizons of Quality

Where is your focus---on the quality of business or the business of quality?

by Mickey Garcia, Segment Manager, Medical Devices, MasterControl

Since W. Edwards Deming’s pioneering work in the 1950s, we have witnessed remarkable progress in the disciplines of both quality and management. Through the years, the best practices of the day have been given fancy names such as total quality management (TQM), Six Sigma and, most recently, Lean everything—just to name a few. With so many hifalutin terms being bandied about, it would be easy to dismiss an emerging term like performance excellence as just another buzzword. But there’s a case to be made for incorporating it more fully into our quality-related vocabulary: to help us, as Dr. Mikel Harry says, look beyond the mere business of quality and focus increasingly on the quality of business.

Dec 3, 2015

The Mysterious "No Fault Found"

Ferreting out root cause can explain the 
reasons behind a "no fault found" condition.

by Harish Jose

Senior Quality Assurance Engineer

As a quality engineer working in the medical device field, I find there is nothing more frustrating than a “no-fault-found” condition on a product complaint. The product is returned by the customer due to a problem while in use, and the manufacturer cannot replicate the problem. This is commonly referred to as no-fault-found (NFF). I could not find a definite rate on NFF for medical devices. However, I did find that for the avionics industry it is 40 percent to 60 percent of all the complaints.

The NFF can be also described as “cannot duplicate,” “trouble not identified,” “met all specifications,” “no trouble found,” or “retest ok.” This menacing condition can be quite bothersome for the customer as well as the manufacturer. In this post, I will define some red flags that one should watch out for and provide a list of root causes that might explain the reasons behind the NFF condition. I will finish off with a great story from the field.

Dec 1, 2015

Inspection Readiness: Leveraging Inspection Focus Areas and Increasing the Transparency of Investigator Oversight

An auditor's goal is to confirm the trial runs 
in a way that ensures the safety of the subjects, 
protects their rights and generates reliable data.

by Jessica Masarek

Quality Assurance Consultant | Independent Auditor

Director, Muse Clinical 

Audits and inspections seem to be wrapped in a shroud of mystery, making folks stressed and unsure of exactly what is going to happen.  What if I say the wrong thing?  What if I don’t know the answer?  What if I can’t provide what they are asking for?  Realistically, all of these things will probably happen!  That said, as long as you are honest, all will be well. Mistakes happen and no auditor or inspector is expecting perfection.  We are expecting transparency.  As an auditor, my goal is to confirm that the trial is run in a way that ensures the safety of subjects, protects their rights, and generates reliable data.  Sponsors want to continue working with sites in which so much effort has been invested and will work to identify areas for improvement if deficiencies are noted.  An inspector has a similar goal with respect to the assessment of trial conduct.  So, how do we ensure that trials are run at the level of quality that regulators are looking for and that are truly inspection ready?