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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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Implementing Data Infrastructure for Advanced Analytics
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Implementing Data Infrastructure for Advanced Analytics

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Plan for the Unplanned: A Quick Guide to Troubleshooting
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Plan for the Unplanned: A Quick Guide to Troubleshooting

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Understanding Failure to Ensure Proactive Maintenance
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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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Why Don’t OEM Recommendations Work for Maintenance?
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Why Don’t OEM Recommendations Work for Maintenance?

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You Can’t Distance From Quality
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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?
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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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Best Practices in Technology Transfer
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Best Practices in Technology Transfer

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...

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The Forgotten Capital Spares
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The Forgotten Capital Spares

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...

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Achieving Capital Project Success Through Organizational Maturity
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Achieving Capital Project Success Through Organizational Maturity

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....

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Are paper batch records slowing you down?
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Are paper batch records slowing you down?

How are batches managed? (more…)

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