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You Can't Distance From Quality

By David Shenberger, June 15, 2020

As an essential business, which must continue functioning in the current global environment, Pharmaceutical Manufacturing companies face unique challenges. Pharmaceutical Manufacturing relies on operating in a controlled state, which stems from Quality Systems in six significant areas. With the current COVID-19 outbreak, this may require adjustments to the way the plant operates typically. Decisions require a scientifically sound process.

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Is CSA Really a Game Changer for the Life Science Industry?

By Brian Stephens, June 11, 2020

Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software Guidance – Is it the solution to arduous validations that the life science industry has been waiting for from the FDA?

Least Burdensome Approach to Validation – the Food and Drug Administration (FDA) has been pushing this concept onto life science companies for the past two decades, with less-than-desired results. The FDA's upcoming CSA guidance promises to be a useful tool to help the industry finally achieve this elusive goal.

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Best Practices in Technology Transfer

By Charlie Maher, May 28, 2020


Technology Transfer and the Product Lifecycle

Technology transfer is integral to the lifecycle of virtually every pharmaceutical product. Tech transfer enables a product to advance from the development lab into clinical manufacturing and then scale-up to commercial production. As demand grows, tech transfer is instrumental in adding additional manufacturing capacity at locations across the globe. Tech transfer may involve site-to-site transfers internal to a sponsor company, transfers between a sponsor company and a CMO (either direction), or from one CMO to another CMO (in or out of network). It is not unusual for a product to undergo multiple tech transfers during its lifecycle.

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The Forgotten Capital Spares

By Robert Smith, May 26, 2020


Preservation Program


What are Capital Spares?

A Capital Spare is a piece of equipment, or a spare part, of significant cost that is maintained in inventory for use in the event that a similar piece of critical equipment fails or must be rebuilt.

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Achieving Capital Project Success Through Organizational Maturity

By John Hughes, April 16, 2020

Every organization has some “big problem” that they need to address. New software, sensors, equipment, or analytics can sometimes be the solution to that problem. But sometimes there is a nagging thought that the real issue is more institutional than asset-based. Almost universally, companies that successfully leap into the Internet of Things (IoT) are already mature, efficient, and agile. They don’t need to solve nagging performance issues. They aren’t looking at software as a solution or performing maintenance by capital project. They’re making a step change to maximize already satisfactory performance metrics.

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Are paper batch records slowing you down?

By Michael Morrison, March 31, 2020

HOW BATCH RECORDS ARE MANAGED

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Quick Glance: Take an Extra 5 Minutes for Safety and Quality

By Brian Nieport, March 26, 2020

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Is Rework Killing Your Packaging Line Efficiencies?

By Tammy Scott, March 6, 2020

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Can Data Centers Save the World with Renewable Energy?

By Ann Schneider, March 6, 2020

Data centers have a significant impact on the global energy market. Current global data center consumption is higher than 2% of all electricity produced, and it is projected by Greenpeace to reach 13% of global electricity demand by 2030 [1]. As a result, data center design is uniquely positioned to influence renewable generation on a global scale positively. Large players in the industry such as Facebook, Microsoft, and Google have pledged to become ‘100% Renewable’ through a collaborative global initiative called RE100 [2]. We’ll discuss: why go renewable, how was it achieved, and where are the renewable data centers located?

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Performance Improvement Strategies that WORK

By Daisy Chew, March 6, 2020

How Key Performer Interviews can help determine root causes for your performance issues and help you develop intentional improvement strategies that work.

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