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The Role of CMAs in Quality by Design (QbD)
By - Kossi Molley (he/him)

The Role of CMAs in Quality by Design (QbD)

The Role of CMAs in Quality by Design (QbD): Quality cannot be tested into a product. It must be designed into it. In the QbD paradigm, Critical Material Attributes (CMAs) are the variables that determine whether that design holds or collapses when raw materials arrive at your dock.

CMA vs. CQA: Understanding the Difference in Pharmaceutical Technology Transfer
By - Kossi Molley (he/him)

CMA vs. CQA: Understanding the Difference in Pharmaceutical Technology Transfer

CMA vs. CQA: Understanding the Difference in Pharmaceutical Technology Transfer: Conflating input material attributes with output product characteristics is a quiet but persistent source of scale-up failure.

The Truth about Manufacturing Science and Technology Innovation Illusion
By - Kossi Molley (he/him)

The Truth about Manufacturing Science and Technology Innovation Illusion

Is Science the true starting point for innovation? Discover why the linear model is failing and how the dynamic cycle of Manufacturing, Science, and Technology Transfer is the real engine of progress.

Risk Evaluation in Biopharmaceutical Technology Transfer: Why a Risk-Based Approach Is Essential for GMP Success
By - Kossi Molley (he/him)

Risk Evaluation in Biopharmaceutical Technology Transfer

Risk Evaluation in Biopharmaceutical Technology Transfer: Why a Risk-Based Approach Is Essential for GMP Success. Successful biopharmaceutical technology transfer depends on more than process knowledge.

Solving the Tacit Knowledge Gap in Pharmaceutical Tech Transfer
By - Kossi Molley (he/him)

Solving the Tacit Knowledge Gap in Pharmaceutical Tech Transfer

Beyond Documentation: Solving the Tacit Knowledge Gap in Pharmaceutical Tech Transfer: This article discuss why Your Documentation Is Not Enough and How to Institutionalize Expert Know-How. Visit us for more…