Why Continuous Improvement is the Key to Sustaining Quality
In the pharmaceutical and medical device industries, achieving high-quality standards is just the beginning. The true challenge lies in...
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kimberlywallbank
- Aug 16
- 3 min
Uniting Forces: The Power of Quality and Regulatory Collaboration
I have written many posts and spoken on many podcasts about the teams within a pharmaceutical or medical device company not working...
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kimberlywallbank
- Jul 16
- 3 min
Becoming a World Class Consultant: Treating Your Clients and Potential Clients with Respect
Building and maintaining strong relationships with clients is vital in the world of consulting. The foundation of these relationships is...
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kimberlywallbank
- Jun 15
- 3 min
The Importance of Reviewing Process Validations in Quality System Elements
In the rapidly evolving pharmaceutical and medical device manufacturing industry, maintaining the highest quality standards is essential....
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kimberlywallbank
- May 16
- 2 min
Three Reasons to Utilize Industry Data for FDA Inspection Preparedness
Preparing for a U.S. Food and Drug Administration (FDA) inspection is a meticulous process that demands a deep understanding of...
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kimberlywallbank
- Apr 18
- 3 min
Turning Criticism into Gold: Harnessing Customer Complaints to Revolutionize Your Products and Processes
Customer complaint data in the pharmaceutical and medical device industries is often treated similarly to other quality systems data,...
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kimberlywallbank
- Mar 19
- 3 min
Enhancing Product Safety and Efficacy: Strenthening Trust With Your Customers
In the realm of FDA-regulated products, be it life-saving medications or innovative medical devices, ensuring product safety and efficacy...
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kimberlywallbank
- Feb 19
- 2 min
Redefining Quality Systems: Unleashing the Power of Efficiency in Pharma and Medical Device Industries
In a recent podcast appearance, I discussed quality systems within pharmaceutical and medical device industries. Specifically, I...
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kimberlywallbank
- Jan 20
- 3 min
Setting the Tone from the Top: Cultivating a Quality Culture
My clients hire me to fix their quality systems. I provide them with the tools to implement a strong and efficient process that will meet...
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kimberlywallbank
- Dec 16, 2023
- 2 min
Ensuring a Merry and Compliant Holiday Season: The Importance of Quality
As the holiday season approaches, we are surrounded by festive cheers, twinkling lights, and the joy of giving. It is a good time to...
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kimberlywallbank
- Nov 18, 2023
- 3 min
The Training Paradox: Unraveling the Blame Game in Deviations and Nonconformances
For FDA-regulated industries, deviations and nonconformances are inevitable challenges. When these issues arise, it is common for the...
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kimberlywallbank
- Oct 4, 2023
- 3 min
The Unseen Pillars: How Your Team Shapes Robust Quality Systems
In the dynamic landscape of modern businesses, establishing robust quality systems tailored to your unique needs is paramount. These...
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kimberlywallbank
- Sep 12, 2023
- 4 min
Five Actions for Effective Standard Operation Procedures (SOPs)
My clients ask me to write SOPs all the time. This is one of their biggest headaches that they would like me to alleviate. It takes...
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kimberlywallbank
- Aug 9, 2023
- 3 min
Use Your Words: Writing Easy to Use Work Instructions (Quality System Documentation Management)
In a previous blog post, I shared that I am an avid knitter. Recently, I completed a cotton summer sweater. Because I am a planner, I...
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kimberlywallbank
- Jul 11, 2023
- 4 min
Hello, Is This Thing On? Understanding What Your Customers Are Telling You (Complaint Handling).
While I work on many different pieces of the Quality System for my clients, the one that I spend the most time on at Quality Systems...
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kimberlywallbank
- Jun 5, 2023
- 2 min
Like Free T-shirts, One Size Quality System Does NOT Fit All!
Most of the calls for help I receive from small pharmaceutical and medical device companies are for SOPs. Their first question is...
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kimberlywallbank
- May 2, 2023
- 3 min
Executing Your Quality System Like a Stanley Cup Champion
When collaborating with my clients, I like to know if they have organizational support, particularly from other departments that are...
9 views0 comments
kimberlywallbank
- Apr 7, 2023
- 3 min
What I Discovered about “Seamless” Quality Systems Through My Knitting
I usually get hired by a pharmaceutical or medical device company to update a piece of their quality system such as complaint handling or...
16 views0 comments
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