Archives

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

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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Don’t Just Close the Tough Human Error Deviations…Solve Them.
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Don’t Just Close the Tough Human Error Deviations…Solve Them.

As most of our industry now recognizes, “Human Error” is not a root cause of issues and deviations. CAI has developed and used a Human...

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Human Error and How History Repeats Itself
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Human Error and How History Repeats Itself

In an industry where the need for accuracy and compliance is essential, there is a category of error which still occurs at an astounding rate,...

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Reducing Human Error in GMP Operations: Building an Error-resistant Workplace from the Ground Up
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Reducing Human Error in GMP Operations: Building an Error-resistant Workplace from the Ground Up

In the pharmaceutical and biotech industries, delays in getting products to market cost companies revenue and inhibit patient access to their medications.  CAI clients often...

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Operational Readiness Consulting in Switzerland
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Operational Readiness Consulting in Switzerland

As of 14 January 2021, Commissioning Agents International Suisse SA is officially open for business. CAI is proud to be able to serve clients across...

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