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Focus on FMEA – Process Risk Assessments (Part 3)

Last week we discussed how to use the concepts of ISO 14971 to create a generalized framework for risk management that works across pharma and is compatible with (and leverages the best parts from) medical devices. This week, we’re going to take that one step further. We will explore how these concepts line up with FMEA/FMECA methodologies.

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ISO 14971 – Process Risk Assessments (Part 2)

Last week we defined a common structure and terms for process risk assessments. This was the first article in a series intended to rationalize and standardize the risk assessment discussion to communicate strategies that provide consistency, objectivity, and risk understanding.

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A Call for Structure – Process Risk Assessments (Part 1)

This blog post series is intended to rationalize and standardize the risk assessment discussion to communicate strategies that provide consistency, objectivity, and risk understanding. Over the next few weeks, we’ll be sharing strategies and approaches that explain how to manage these situations.

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Structured data frameworks needed to enable efficient knowledge management

While many industries have moved to adopt the latest technologies and practices to improve their operational efficiency and lower costs of production, the pharmaceutical industry has been slow to keep pace, especially with respect to manufacturing.

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Are you controlling your process? Or is your process controlling you?

Quality by Design is not new. The process of building quality into your manufacturing method and product is not simple; however, what QbD does, is simplify the complexity that it involves. Here’s how.

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RIP: Spreadsheets and Fishbones

The industry is still married to spreadsheets and fishbone diagrams for risk assessment and for understanding cause-and-effect relationships between process and product requirements. Here’s why those tools may no longer be sufficient.

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The Paradigm of Pharma Manufacturing is Shifting

Modern medicine is stepping into an exciting and promising renaissance with a wave of small-batch cell, gene and curative therapies receiving regulatory approvals. Sixteen months …

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FDA Publishes New Paper on KASA: Why Knowledge Management is Critical to the Drug Industry

Last week the FDA published a paper on its pharmaceutical quality assessment system: Knowledge-aided Assessment & Structured Application (KASA) in the International Journal of Pharmaceutics: …

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Early Discipline in Biotech/Pharma Startups

In the context of product lifecycle management in the pharmaceutical and biotech industries, the discipline of scientific rigor is critical. Here’s why.

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