What's New at CQS

CONTRIBUTED GUEST COLUMNS:

7 Steps To Properly Navigate An Event Investigation
A recently published article examining recent GMP inspection data from CDER (FDA’s Center for Drug Evaluation and Research) and MHRA (Medicines and Healthcare products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list [of the most frequently cited observations] over the past four years. We as an industry cannot seem to get this quite right.” I agree. Here’s why.
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The 4 Pillars Of A Voluntary QA Culture: How Does Your Company Measure Up?
The U.S. Food and Drug Administration (FDA) cites corporate culture as a root cause of many compliance issues. It also says a strong quality culture “can lead to sustainable compliance.”1 How can pharmaceutical companies encourage a quality culture that empowers employees to own quality, so they operate in ways that allow maximum performance and safe, effective products?
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LINKEDIN POSTS:

How to Craft a Well-Written SOP
Many deficiencies identified in FDA’s 483s and Warning Letters can be traced back to SOP deficiencies—inadequately written, communicated, monitored, and/or enforced.Well-written SOPs provide clear instructions, avoiding deviations. With a reduction in deviation, organizations can maintain compliance, deliver a quality product, and ensure patient safety.
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  SOPs

"The Fundamental 5" SOP Training for Everyone
Quality experts know that SOP training has positive effects on a company’s performance and success. Yet senior executives can resist even a minimum amount of training,especially when they do not operate daily in a GxP environment.
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  trainig

Building the Best Foundation for Your Training Programs
Today, we want to discuss elements that make for a strong foundation for such a program.Remember the goal is to maintain compliance while ensuring employees efficiently master required techniques and current operating procedures and protocols. 
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             foundation

Bulletproofing Your Training Programs
Among the 40 GMP drug warning letters issued by FDA in Calendar Year 2015 for data integrity deficiencies, 12 (30%) made note of either a lack of training or the need to include training or re-training in corrective and preventive action (CAPA) improvements. 
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  bulleetproff

Five Lessons for Building a “Voluntary QA” Culture
Lesson 5: “Retail politics and campaigning for Quality”
As we come to the close of this election cycle (with much thanks and relief), today we delve into how “retail politics” can help Quality be more successfully integrated into everyday activities.
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Five Lessons for Building a “Voluntary QA” Culture
Lesson 4: “Be a part of the team ….”
In my role, I help companies remain compliant and people remain sane. At the core of this, I must be able to build trust and collaboration among many different people, and one way to achieve this is for me to build great teams.
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Five Lessons for Building a “Voluntary QA” Culture 
Lesson 3: “Think like a teacher”
Dictators don’t engage people they don’t focus on the “why,” only the “what.” They demand action, no questions asked. Educators, rather, engage people by focusing on helping them understand the “why” of Quality so they are better prepared and equipped to work on the “how.”
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Five Lessons for Building a “Voluntary QA” Culture
Lesson 2: Fire Prevention vs. Firefighting
Quality - like fire prevention - is everyone’s responsibility. What happens when only firefighters (or Quality departments) are responsible? They run all over looking for fires, always on alert and in a constant state of crisis. An alternative is to educate people and offer well thought-out education programs … 
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Five Lessons for Building a “Voluntary QA” Culture
Lesson 1: Think like a Coach instead of a Cop

Responses to our last post were quite positive (Thank You.), so I wanted to provide more details around building a “Voluntary QA” Culture. The first lesson: “Think like a coach instead of a cop.” 
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Five Lessons for Building a “Voluntary QA” Culture
Do we really have to do that? Isn’t there some sort of "QA-lite" solution?

Having been asked this question many times, I see it as a red flag, but to be fair, this question comes from people with the perspective that GMP is burdensome and as such translates to “Great Mounds of Paper.” 
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“Voluntary QA” Bulletproof Research Practices and Data Collection
A Fire Extinguisher in the Corner

A great article in January’s Nature spells out what I believe to be a new movement in Quality Assurance (QA). The article discusses “Voluntary QA” and how it can: 1) Improve overall data Quality and research practices. 2) Develop research processes that prevent issues before they happen. 
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