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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Commissioning During COVID-19

Life has been turned upside down during the COVID-19 pandemic with travel restrictions, self-isolation/ quarantining requirements, and social distancing measures implemented to slow the spread...

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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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Blog Post

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

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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Blog Post

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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Blog Post

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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Blog Post

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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New email domain, same CAI. We’re updating our emails to match our web domain. Full transition by October 3.