Austin Caudle
Austin Caudle, Vice President at SmartSkin Technologies
Raleigh, North Carolina, United States
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Austin Caudle, MSc
Vice President, SmartSkin Technologies
A seasoned pharmaceutical quality thought leader, Mr. Caudle has over two decades of experience across pharmaceuticals, biotech, and medical devices, specializing in bridging technology with critical industry needs to advance quality and patient outcomes. He actively shapes industry standards as Immediate Past-President of PDA Southeast Chapter, a member of the PDA Regulatory and Quality Advisory Board (RAQAB), and a Regulatory Authority Engagement Liaison for the EMA Quality Working Party. He also contributes to ISPE CaSA Chapter and is a frequent contributor to discussions on data integrity, quality maturity, and regulatory science.
His extensive career includes roles at Fortune 500 companies (Kelly Science & Clinical, IQVIA, ThermoFisher), leadership at NSF Health Sciences and Charles River, and establishing Redica Systems as a leader in Quality and Regulatory Intelligence software. At SmartSkin, he drives strategic partnerships and customer engagement to accelerate technology adoption, empowering manufacturers by focusing on damage prevention, process control, and regulatory confidence.
Austin holds a BSc and MSc in Nutrition & Food Science from Auburn University and has published research in scientific journals.
Area of Expertise
Topics
Accelerating Process Validation for Injectables with Digital Container Twins
The landscape of Chemistry, Manufacturing, and Controls (CMC) is becoming increasingly intricate, driven by the rapid confluence of Industry 4.0 and the digital age, the rising demand for biology-centered therapies, and the necessity for business transformation. Traditional methods are no longer adequate to address the complexities of achieving "Compliance through Science" across pre-commercial, commercial, and post-commercial activities. A new approach to data acquisition and process understanding is essential.
This presentation directly addresses this challenge by showcasing the scientific potential and practical utility of a digitally empowered technology: SmartSkin Digital Container Twins. These "smart" replicas of vials, syringes, or cartridges create a unique signature of the product-equipment interface, generating measurable, transferable electronic data that directly correlates with processing parameters.
We will share compelling case studies demonstrating how this technology provides novel insights and agility for advancing products and processes through all validation stages (Stage 1, 2, and 3). Attendees will discover how Digital Container Twins can enhance process performance, simplify technology transfers, accelerate change management (DEV/CAPA), and ensure adherence to current and evolving regulatory standards for injectable products. This session offers a clear roadmap for increasing know-how and product quality in the digital era.
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