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Thought Leadership

How A Digital CMC™ Platform Enables Rapid Tech Transfer

In this installment of QbDVision’s Knowledge Management Lab, we discuss how developing an internal digital knowledge management capability for your organization can translate into operational excellence based on agile management principles.

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No. It’s never too early to think about quality!

When should early-stage companies should begin thinking about implementing quality systems? Here’s why the answer is “yesterday.”

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What is a Knowledge Management Lab?

Welcome to our effort to facilitate discussion and experimentation with best practices and novel tools as oure industry looks to accelerate product development, manufacturing scale-up, and technology transfer.

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ICH, QbD, Pharma 4.0: One and the Same

There is a consistent theme that comes up in the world of pharmaceutical process development and validation: a pervasive confusion around how ICH guidelines match up with quality-by-design principles.

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The Non-Linear Factor: People – Process Risk Assessments (Part 5)

Last week, we saw how capturing uncertainty and detectability risk brings clarity and dimension while assessing risk when used appropriately. This week, we will look at the practical aspects of process risk assessments from a different lens: that of the people executing or using these tools.

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The Impostors: Uncertainty and Detectability Risk – Process Risk Assessments (Part 4)

Last week we explored how the concepts we’ve been discussing in our series line up with FMEA/FMECA methodologies. This week, we’ll explore the two impostors, uncertainty and detectability risk, a little bit further.

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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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