FDA modernizes compliance processes for regulated industries
- The FDA is modernizing its technology and processes to ensure compliance in FDA-regulated industries.
- An online training event will be held on December 9-10, 2024, to discuss data integrity and best practices.
- Professionals will learn about Pharma 4.0 and its role in improving compliance and public health.
In Dublin on December 2, 2024, the "All About Data Integrity by Design" training was announced by ResearchAndMarkets.com, aimed at professionals involved in computer system validation in FDA-regulated sectors such as pharmaceuticals, medical devices, and tobacco products. The purpose of this online event, set for December 9-10, 2024, is to share insights on the ongoing modernization initiative by the FDA. This initiative focuses on updating technology and processes to enhance industry collaboration, ensuring regulated products comply with FDA standards while expediting market access for these products which can ultimately affect public health positively. The session will explore several methodologies and best practices, including Pharma 4.0's operating and maturity models that advocate for proper integration of information technology with organizational practices, alongside risk assessment grounding. Attendees will gain valuable knowledge of current and emerging practices that ensure data integrity in compliance with regulatory expectations and foster innovation in their operations. The event will be led by noted professionals like Carolyn (McKillop) Troiano, whose extensive background spans over three decades in FDA-regulated industries, illustrating the importance of industry expertise in ensuring product compliance. This focus on transformative practices is aligned with the FDA's commitment to modernizing how they work with the industry, ultimately leading to improved public health outcomes as companies can bring their products to market more swiftly and safely.