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Blog

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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Blog

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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Blog

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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Blog

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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Blog

Unstructured vs. Structured Data

The discussions around “unstructured data” vs. “structured data” in the context of pharmaceutical submissions have begun in earnest. Catch up with the debate.

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QbD is more than just DOE…a lot more

As I talk to people about managing process development activities under a Quality-by-Design framework (QbD), people equate Quality-by-Design (QbD) with Design of Experiments (DOE). There are important differences.

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Blog

Has eCTD outlived its usefulness?

The eCTD format provides large amounts of unstructured text in PDF format which leads to lengthy and redundant reviews because the key information is buried in the documents.

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