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Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities
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Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities

Let’s contrast two very real scenarios: You are responsible for bringing a new GMP facility or line to full-scale production. Your board or shareholders expect...

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Technology Transfer Project Management Best Practices in the Era of COVID-19

Technology transfer is essential to advancing pharmaceutical products from development, through clinical and into commercial operation.  The complexity of transferring the production of a product...

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Project Management “Impossibilities” – Running the Project Management Marathon

Running a race is easy, right? You get up early on a Saturday morning, lace up your sneakers, get in line and go. You eventually...

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QRM and the System Classification “Big Reshuffle”: Don’t Miss the Forest for the Trees

Recently, under its new Insights offering, KenX published an article, The Big Reshuffle – Impact Assessments and System Criticality, discussing the implications regarding the change...

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Understanding Failure to Ensure Proactive Maintenance

In today’s highly competitive environment, eliminating unplanned downtime is more important than ever, especially when that downtime occurs during a batch that places the product...

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You Can’t Distance From Quality

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...

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

Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software Guidance – Is it the solution to arduous validations that the life science industry...

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