Rose Mary Aversa

ProQuality Network
Vice President, Compliance Operations
A dynamic leader in healthcare quality, compliance, and operational excellence. With deep expertise in cGMP, regulatory standards, and validation, she develops and implements science- and risk-based quality systems that ensure compliance and optimize performance. Passionate about advancing regulatory readiness and fostering continuous improvement, Ms. Aversa specializes in FDA inspection preparedness and modernization of pharmaceutical operations. Currently serving as Vice President of Compliance Services at ProQuality Network, she is dedicated to empowering businesses with strategic solutions that drive quality, safety, and compliance.

Related Articles

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iSpeak Blog
AI Inspection Readiness: A Practical Structure for Preparing Teams, Systems, and Evidence

AI is now part of many daily quality and manufacturing activities. As uses of AI grow, inspectors will expect clear explanations of how AI-enabled systems impact GxP decisions and how companies keep them under control. Inspection readiness becomes essential because AI systems introduce new risks, new types of documentation, and new types of expertise.

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iSpeak Blog
Navigating the US Food and Drug Administration (US FDA) Outsourcing Facility Inspections Compliance Program
At the 2025 ISPE Annual Meeting & Expo in Charlotte, North Carolina, USA, the authors presented on the US FDA Outsourcing Facility Inspections Compliance Program (7356.040) and the broader regulatory landscape shaping expectations for outsourcing facilities. The session brought together leaders in pharmaceutical quality, regulatory affairs, sterile manufacturing, and the compounding community....