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Feb 16, 2017

Quality Pros & the Oscars: Films to See Based on Your Personality

by Cindy Fazzi


Editor, MasterControl Insider


It’s Oscar season! From Seattle to Shanghai, movie fans are talking about their favorites, and maybe betting in their Academy Award office pool or its equivalent overseas. Watching Hollywood films is the world’s favorite pastime, judging by the U.S. film industry’s box-office revenues, which exceeded $11 billion in 2016 (1).

In the universal language of film, quality management is not all that esoteric. There’s a perfect Oscar-caliber movie for everyone regardless of age and background. Take a look at the personality types below. Which type are you?

Check out the Oscar-winning films that match your personality. If you’ve already seen them, watch them again! What better excuse to indulge in buttery popcorn and cheese-smothered nachos at home than watching a movie?

Feb 13, 2017

Recognizing the True Heroes of Life Science on Donor Day



An organ donation is the greatest gift one can give --
a single donor can save as many as eight lives


by James Jardine


Marketing Communications

MasterControl




The United Network for Organ Sharing (UNOS) estimates that an average of 22 people die every day because the organs they need to survive are not donated in time to save their lives. Five years ago, I was within days of becoming one of those death statistics. But the heroic actions of someone I will never know ensured that my two sons still have a father. While some may only turn their thoughts to organ donors every February 14th on National Donor Day, my gratitude manifests itself daily.

Feb 9, 2017

ISO, Regulatory Requirement Changes Loom

Several ISO quality management standards  
are changing.  Be aware of your deadlines!


by B. Christine Park


CQA, CQM/OE

Consultant



As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:


Feb 7, 2017

How to Lead with Respect

Orzen says that companies aren't 
experiencing employee engagement 
because they neglect the
"Respect for People" pillar.


by Doug Bartholomew


“Over time I’ve come to realize that engaging in this problem-solving process is actually the highest form of respect….The manager truly respects the employee’s knowledge and his or her dedication to finding the best answer….Only by showing mutual respect-- each for the other and for each other’s role-- is it possible to solve problems, make work more satisfying, and move organizational performance to an ever-higher level.”
                                           --Jim Womack, Gemba Walks, Expanded 2nd Edition, p. 5

At every organization that has embarked on a lean transformation, managers are well aware of the need to “show respect” for their people. In fact, respect for people is one of the pillars of the Toyota Way. Thus, when asked, lean managers will tell you that “employees should be treated fairly, given clear goals, trusted to achieve them in the best way, and held accountable for results,” writes Jim Womack, lean management expert and founding CEO, Lean Enterprise Institute (LEI).

Feb 3, 2017

EU Policy 70 and Redaction — PleaseReview’s Take on It

Complying with EMA's transparency policy
means much of the published clinical
documentation must be redacted to 
remove personal private data.


by David Cornwell


Founder/CEO 

PleaseTech Ltd.


This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.

Feb 2, 2017

Your Top 10 Questions About ISO 13485:2016—Answered!

This Q&A will help you develop and implement 
a successful 13485:2016 transition plan.


by Lisa Weeks 


Marketing Communications Specialist

MasterControl 


In early 2016, the International Standards Organization (ISO) published the long-awaited revised version of ISO 13485:2016, the standard which provides device makers with a framework for establishing a quality management system (QMS). Because it is the first major revision to the standard in 13 years, questions abound. In this post, we will tackle the most common questions asked by attendees during the many ISO 13485:2016-centric webinars we offered last year. We will also tap into the expertise of Quality Architech Christine Park, founder and president of Christine Park & Associates, and a frequent contributor to GxP Lifeline.