CAPA

Topic: CAPA To avoid FDA enforcement actions, companies in regulated industries must prioritize CAPA implementation and continually improve their quality management systems. By demonstrating a commitment to CAPA and ensuring product safety, companies can maintain regulatory compliance, build trust with consumers, and protect their reputation in the market.  To avoid enforcement actions and maintain compliance […]

Topic: CAPA In regulated industries such as pharmaceuticals, medical devices, and food production, adherence to CAPA processes is of utmost importance. The U.S. Food and Drug Administration (FDA) plays a significant role in ensuring compliance with CAPA requirements. During inspections and audits, the FDA assesses an organization’s CAPA system to determine if it meets regulatory

Topic: CAPA The CAPA process involves several key steps to effectively address and manage issues while striving for continuous improvement: Identify and Document the Issue: Whenever an issue, non-conformity, or potential risk is identified, it should be documented in detail. This includes capturing the problem’s scope, potential impact, and any available evidence related to the