Newsletter | February 20, 2024

02.20.24 -- Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma

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FEATURED EDITORIAL

Decoding The FDA's Draft Guidance On Computer Software Assurance

In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. Review the key elements of the guidance.

INDUSTRY INSIGHTS

Bioprocessing 4.0: Digital Transformation Of Process Development

Discover how, in combination with artificial intelligence, augmented reality, robotics, and digital twins, biopharma 4.0 is changing legacy concepts from the ground up.

The Importance Of Steel Quality In Pharmaceutical Tablet Tooling Operations

In manufacturing, nothing is more important than the quality of the materials being used. Explore why steel quality is the fundamental building block upon which all successive value-added steps are laid. 

Manufacturing Dry Powder Inhaled Formulations By Spray Drying

Kimberly Shepard, Ph.D., principal engineer in R&D, addresses the challenges associated with spray-drying late-stage lung cancer treatments, including proteins, peptides, and mAbs.

Integration Of Quality Management And Manufacturing Automation Systems

Quality by design (QbD) is enormously valuable but often underutilized, siloed, and not operationalized. Learn about the benefits of enabling QbD with AI-driven quality operations and batch automation.

Aseptic Blow/Fill/Seal Technology vs. Traditional Aseptic Processing

See why blow/fill/seal technology has been gaining increasing worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing in a growing number of applications.

Integrating Early Development With Clinical Supply

In the era of seamless development, reducing time to the clinic and getting rapid approval is key. An integrated approach can accelerate timelines, avoid communication pitfalls, and improve outcomes.

7 Parameters To Consider When Conveying Toxic And Explosive Powders

In order to maintain the highest standards of safety, sustainability, and hygiene, several crucial factors must be addressed to ensure these powders are moved without any danger to the operatives.

What Is An Aqueous Cleaner?

This chapter of The Aqueous Cleaning Handbook explains what an aqueous cleaner is, what it contains, and how it can improve your cleaning process.

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