Mr. Tulasi Naga Subhash Polineni

Enhancing Regulatory Compliance in Healthcare: Addressing the Challenges of Adherence to FDA Guidelines and Standards

Abstract:

Regulatory compliance is crucial for maintaining safety, efficacy, and quality in healthcare, particularly in the context of adherence to U.S. Food and Drug Administration (FDA) guidelines and standards. This paper explores the challenges healthcare organizations face in ensuring compliance with FDA regulations, including the complexity of evolving rules, the impact of technological advancements, and the resource constraints of healthcare institutions. It examines the gaps in knowledge and practices that hinder full adherence and offers strategies for overcoming these challenges, such as improved training, streamlined processes, and the integration of advanced technologies like automation and artificial intelligence. The paper also discusses the importance of fostering a culture of compliance within healthcare organizations and the role of leadership in driving regulatory adherence. By addressing these challenges, healthcare providers can better ensure patient safety, minimize risks, and promote continuous improvement in healthcare delivery..