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Apr 27, 2017

"We're Different!" Overcoming the Challenges of Applying Lean Principles to Knowledge Work



Lean process improvement techniques 
can be applied to knowledge work and
knowledge workers.

by Drew Locher

 

President

 

Change Management Associates


If you are applying lean management principles to R and D, life science, or other knowledge work processes, you’ve probably heard the "we're different” argument. It usually goes something like this, “You can’t apply lean process improvement techniques to creative work because everything we do varies."

Knowledge work and knowledge workers are different. But that doesn't mean process improvement concepts don’t apply. It does mean we have to adapt the concepts and approaches by practicing these proven techniques.

Apr 24, 2017

20 Years Later, 21 CFR Part 11 is More Relevant than Ever


by Cindy Fazzi


Staff Writer, MasterControl


If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

First off, what’s new with Part 11? Every now and then, there are rumors about updates. The on-again, off-again speculation stems from the FDA’s “Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application.”

The 2003 guidance says: “While the re-examination of Part 11 is underway, we intend to exercise enforcement discretion with respect to certain Part 11 requirements” (1). And yet, neither re-examination nor update is apparent.

Apr 20, 2017

What Do Food Facility Auditors Really Want? A Practical Guide to Reducing Your Audit Stress Level


Does preparing for your next
audit give you a headache? PDCA
may help reduce your audit stress.

by Bryan Armentrout


CEO, The Food Leadership Group


Third party audits are critically important to food companies. They are the primary tool your customers use to determine if adequate food safety systems are in place. This article covers some of the strategies and tactics you should employ to maximize your chances of a successful audit.

Does this Scenario Sound Familiar?

A big audit is coming up. The plant has been preparing for months and this is the final team meeting before the auditor arrives. At some point during the meeting the plant manager turns to the quality assurance (QA) manager and says, “Are you ready for the audit?” The QA manager swallows hard and responds, “As ready as we are going to be.”


Apr 18, 2017

Human Factors: Why it is Critical in Designing Medical Devices

Human factors helps design out 
the opportunity for human error

by David Jensen

MasterControl Staff Writer


“Most of the time spent wrestling with technologies that don’t quite work yet is just not worth it for end users, however much fun it is for nerds.” 
---Douglas Adams.

This quote hints at the importance of human factors in technology in medical device design and development. Rollin Fairbanks, director, National Center for Human Factors in Healthcare, talked about human factors and its critical role in medical device design at the PDA/FDA Joint Regulatory Conference in Washington D.C., Sept. 12-14, 2016.

Many issues or mishaps involving medical devices can be attributed to human error. However, instead of focusing on discipline, mindfulness and training of end users, Rollin stressed that human error cannot be eliminated, but it can be significantly reduced with the right approach to product design.

Apr 13, 2017

Site Selection: Don’t Forget About the Study Drug

When conducting GCP audits,
many criteria must be checked
including those that affect the
drug you are testing.


by Laurie Meehan


Social Media Manager


Polaris Compliance Consultants, Inc. 



As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and timeframes, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient database and assessing inclusion/exclusion criteria. They’re reviewing staff credentials and ensuring they have adequate resources to manage the number of subject visits and collect the data the protocol requires.

But when we conduct GCP audits, we find there’s one perspective that is sometimes overlooked by both sides: the needs of the study drug itself. 

Apr 11, 2017

Top 5 Takeaways from MedTech Intelligence’s Medical Device Cybersecurity Conference

by David Jensen


MasterControl Staff Writer


I recently attended a conference on Medical Device Cybersecurity hosted by MedTech Intelligence held March 23-24, in Washington, DC. It’s evident that cybersecurity is an important concept as attendance, both in-person and remote, was high. Conference organizers lined up a powerhouse group of presenters who are all entrenched in the technology, cybersecurity, legal and regulatory compliance industries.

For two days, attendees had the opportunity to hear from and converse with officials from FDA, cybersecurity experts from the Mayo Clinic and the Medical Device Innovation Safety and Security (MDISS) Consortium, attorneys specializing in life sciences and healthcare and engineers in medical device manufacturing.

For those of you who were unable to attend this event, here are my top 5 takeaways:

Apr 6, 2017

4 Rules for Building an eClinical Qualification Framework


by Rob Sims


UL Compliance To Performance


Marketing Programs Manager


As clinical trials continue to expand globally, technology plays a critical role in maintaining data integrity and at the same time accelerating study start-up. Consider a study management team that must travel globally to hold investigator meetings. Travel now takes up a much greater portion of the study management team’s time and energy.  That’s why study teams have turned to eClinical technology to reduce this effort – from preclinical R&D and regulatory communication to packaging/distribution and post marketing studies. 

In this clinical ecosystem is also site personnel qualification technology, which must be targeted to each role within the clinical research site. Otherwise, individuals within the site would receive too much or not the right protocol and non-protocol items that align with their role.

Apr 4, 2017

How to Practice Quality Management in Your Personal Life


by Paul Sanderson


Solutions Consultants Manager


MasterControl


“Quality management” is one of those terms that sounds so simple and esoteric at the same time, like DNA or free cash flow. I’m pretty sure I know what those terms mean until I start explaining them to someone. 

I've worked in the quality software business for over 12 years, and I still don't know what to say when someone asks me what I do for a living.

It generally goes like this: