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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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AAV Vector Production

Overview Until about 2016, the majority of vectors used in gene therapy were Adenovirus and Retrovirus vectors.  In recent years, a change toward Lentivirus and...

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What is Proactive Commissioning?

In Maintenance and Reliability, there are a complete set of tools dedicated to Proactive Maintenance.   (more…)

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Predictive Maintenance Technologies

Predictive Maintenance (PdM) technologies are not just for use after your equipment has been installed.  Many of these technologies can be applied during the various...

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Human Error and Uncertainty

Why competent people make costly errors, and how to address it. (more…)

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Commissioning Teamwork

How to best develop good teamwork across the General Contractor, subconsultants, CxA, and Operations during a project. (more…)

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E-Pub: The Importance of Annex 1

Annex 1 - "Manufacture of Sterile Medicinal Products." was first published in 1971. However, the first revision since then is currently in process. And this...

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