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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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Transformative Power of Virtual Twins (Part 3 of 3)

This is the final installment of a three-part series exploring the transformative power of Virtual Twins as part of an asset induction effort for facility...

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Blog Post

Transformative Power of Virtual Twins (Part 2 of 3)

This is the second installment of a three-part series exploring the transformative power of Virtual Twins when applied to an asset induction effort for facility...

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Blog Post

Transformative Power of Virtual Twins (Part 1 of 3)

This is the first installment of a three-part series exploring the transformative power of Virtual Twins when applied to an asset induction effort for facility...

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Blog Post

Five Keys to Successful Facilities Management

Facilities Management is a critical aspect of maintaining a safe and efficient workplace. It involves a wide range of tasks, from maintaining the physical infrastructure...

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LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 1 – PLANNING

After several years of conversation with drug manufacturers and consultants about the state of computer system validation, the FDA issued a draft of the Computer...

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Remote Regulatory Assessments – Q&A: Here to Stay

On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs).  The FDA has...

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Implementing a Risk-based Approach to Calibration 

How does your organization determine calibration test points, tolerances, and frequency? A simple rule of thumb to calibrate instruments at 10, 50, and 90% of...

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FDA Quality Management Maturity Program

Drug shortages in the pharmaceutical industry is a significant concern that has far-reaching consequences for the industry, the regulators, the healthcare system, and ultimately the...

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The Readiness Stage of Technology Transfer 

During a pharmaceutical technology transfer (TT) project, the Readiness Stage plays a pivotal role by establishing the groundwork for a successful transition. This phase involves...

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