Archives: Seminars

An Engineering Approach to Improving Essential Medicine Access – A Case Study on Liposomal Amphotericin B

Applying the Manufacturing Classification System (MCS) to Continuous Processing

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Crafting a Gastric-Resistant Coating From Natural Ingredients: An Innovative Wax-Based Enteric Coating for Pharmaceutical and Nutraceutical Oral Products

Accelerate Time to Market: Why it’s Essential to Select the Correct Primary Packaging for Your Formulation at the Earliest Stages of Development

A comprehensive look at how your choice of primary packaging can impact time to market. We start by covering the minimum requirements for primary parenteral drug packaging – ensuring that the packaging that comes into direct contact with your formulation meets standards set out in the EP, JP and USP. From there we talk about… Read more »

Computer Software Assurance: FDA’s New Approach to Computer System Validation

A draft guidance of Computer Software Assurance (CSA) for Production and Quality System Software has been recently issued by the FDA. This new guidance, together with the second edition of the GAMP 5 guide, have shifted the emphasis away from indiscriminate scripted testing and documentation, towards more critical thinking and a risk based testing strategy…. Read more »