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fall-2019-scientist

Life Sciences: Understanding the basic differences between Validation and Calibration

The Life Sciences market is evolving at breathtaking speeds these days, and the rapid rise in product innovation and cell therapy technology across the life science market is calling for companies to have a more robust quality and compliance approach in order to meet regulation and produce safe and reliable products. Good manufacturing practice (GMP) […]

The Life Sciences market is evolving at breathtaking speeds these days, and the rapid rise in product innovation and cell therapy technology across the life science market is calling for companies to have a more robust quality and compliance approach in order to meet regulation and produce safe and reliable products.

Good manufacturing practice (GMP) regulators in the United States the European Union and other internationally recognized GMP regulators have sharpened their focus on quality and compliance practices. Driving this trend is a shift in regulatory thinking from quality-by-test to quality-by-design systems/processes with emphasis on the level of risk to product quality and patient safety.

There’s an increased emphasis by regulators in the Healthcare and Life Sciences (HLS) industry to comply with rules and regulations across all aspects of their business, such as development, design, equipment operation, processes, test methods, standard operating procedures, computerized systems, and data security amongst other things. Realizing there is an urgency for growth, leadership, and knowledge that can serve and grow with our ever-changing industry, I wanted to share some basic insights from within my profession that seem to come up more often as people enter the regulated space of the Life Sciences industry.  Validation, calibration, and qualification are extremely critical in Healthcare and Life Sciences processes. Understanding them is necessary in order to meet GMP guidelines.

I’m often asked; “What is the difference between calibration vs. validation – are they the same? Is one a subset of the other?”

“I am still struggling to separate the two from each other – Can you provide me with a definition of Calibration vs. Validation and how the two differ.”

At the most basic level, calibration indicates the error of an instrument and measurers for any lack of trueness by comparison against a reference standard and validation stands for a process of testing and documenting.

Many people in the Healthcare and Life Sciences industry know the terms, but not everyone is aware of the differences.

Just a little insight will help you understand the differences between them.

Validation is the documented act of demonstrating that a procedure, process, and activity will consistently produce results meeting predetermined acceptance criteria. Pharma & Biotech’s most common way of establishing evidence or documenting test results is through the implementation of Protocols. Protocols, such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), along with essential design and planning documents such as User Requirement Specification (URS) and Validation Master Plan (VMP) are the building blocks of the validation framework.

Why is this essential? ‘If it’s not written down, then it didn’t happen!’

The FDA requires establishing documented evidence that a specific process will consistently produce results meeting specifications and quality attributes. Without supporting documentation, one runs the risk of being out of compliance.

Calibration on the other hand specifically refers to measurement devices, instruments and tools that record, monitor, and control environmental conditions or parameters. Calibration can also be defined as a process that demonstrates a particular instrument or device to produce results within specified limits with reference to a traceable standard over a range of parameters. This process also includes the adjustment of an instrument to realign with the acceptable standard.

Taking measurements involving any GxP process requires calibration to ensure the accuracy of the measurement. Instruments that record, monitor, control critical environmental variables require calibration. Instrument calibration must be enforced on a regular basis to ensure reproducible results. GMPs require written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.

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Understanding these generally basic concepts are an integral step to understanding quality assurance and the many different aspects of compliance in the Life Sciences industry. It all might seem like a long, drawn-out process, but there’s a good reason for it. If you can ensure your products perform consistently and meet all the requirements of the industry, the value of both the product and patient safety increases. Along with this increased value comes a greater need to understand that the work we do matters, and that helping Life Science organizations ensure compliance and consistency with current regulations when carrying out commissioning, validation and qualification projects in a safe and efficient manner ultimately leads to saving lives.

 

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Are you running your meetings or are your meetings running you?

What is it about meetings that make you crazy? Most of us hate meetings because they’re boring or frustrating (or both), they don’t accomplish much, there are distractions, they’re sporadic, they’re never focused, filled with unnecessary people and so on. On average, business leaders rate the effectiveness of their team meetings as a 4 out […]

What is it about meetings that make you crazy? Most of us hate meetings because they’re boring or frustrating (or both), they don’t accomplish much, there are distractions, they’re sporadic, they’re never focused, filled with unnecessary people and so on. On average, business leaders rate the effectiveness of their team meetings as a 4 out of 10. So how do you fix this problem?

As a Professional EOS® Implementer, I would suggest implementing a productive weekly meeting that is held on the same day of each week, at the same time each week, use and follow the same agenda each week, and it must start and end on time. Having the meeting at the same time every week helps with individual accountability because people know when they leave the meeting that they have seven days to accomplish the tasks they’ve been assigned and that they’re going to be asked about it at the next meeting. This automatically builds traction into your operations.

The Level10 Meeting™

This weekly meeting is known as a Level10 Meeting, introduced in the book Traction: Get a Grip on Your Business, by Gino Wickman. It provides an opportunity to ensure that everything is on track for the week, which in turn ensures that everything stays on track for the quarter. It is designed to help your teams create a consistent rhythm that keeps the company focused, organized, on task, and encourages you to manage and handle conflicts and resolutions. We call it Level10 because one of the things we ask new clients to do is rate the effectiveness of their meetings on a scale from 1-10, with ten being the best. The average meeting is usually rated a four, but after teams start using the Level 10 Agenda, the ratings skyrocket.

The Five Points of the Weekly L10 Meeting

A productive meeting pulse should meet the following five criteria:
1.Same day 2. Same time 3. Same agenda 4. Start on time 5. End on time
With a normal meeting, there is typically a dynamic I am going to share with you, which is illustrated in the following procrastination model.

If your normal, here is what typically happens with activity — coming out of meeting A there’s stuff to be done and typically just before the next meeting everyone rushing to get everything done.

It’s called procrastination, and it just makes us normal.  To the degree, we can increase that meeting interval, we create that spike in activity more often, increasing the meeting pulse moving us towards utopia. You come out of the shoot running, so there’s no time to procrastinate. That’s what the meeting pulse will do for you; it’ll become the heartbeat of your organization.

If every meeting follows the same agenda, is held on the same day and time each week, and has a solid start and end time, your Level 10 Meetings will accomplish its goals and take your business to the next level. The key to successful and productive weekly meetings is to keep them consistent and to always start and end on time.

“Early, is on time, and on time is late.”
— Vince Lombardi

Starting a weekly meeting late almost always results in less time to solve your issues, which is the most important part of the meeting. Teams should aim to spend around 50% of these meetings solving issues.

To ensure that you are staying on track and maintaining a pulse on the business, be patient with the weekly meeting process and over time, you’ll see a notable rise in the health of your team and improved communication throughout business.

To Recap:

In order to fix the problem of low productivity and effectiveness in your company’s team meetings – implement the Weekly Level10 Meeting and get a pulse on your business. Pick the ideal day and time for your team and get your first Level 10 meeting on the schedule.

Next Steps:

To learn more about The Weekly Level10 Meeting Agenda contact Nathan Roman, Professional EOS Implementer at nroman@nextstepistraction.com
To obtain by mail your free hardcover copy of the book Traction: Get a Grip on Your Business, by Gino Wickman; reach out to nroman@nextstepistraction.com

Follow me on Facebook @nextstepistraction or connect via LinkedIn @ www.linkedin.com/in/nathanroman/

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