The COVID-19 pandemic has led to a significant backlog of delayed inspections, and the FDA is now prepared to hire additional employees and substantially increase the rate of inspections to address this issue. This heightened inspection activity means an increased likelihood of your organization facing an audit, underscoring the importance of having an effective strategy for investigating quality deviations.
In response to this pressing need, MasterControl has partnered with regulatory experts from Regulatory Compliance Associates (RCA) for an exclusive virtual event. This event will focus on best practices for investigating quality deviations, providing essential guidance to help you manage quality events and navigate the challenges of increased FDA scrutiny.
Join Sue Schniepp, RCA Distinguished Fellow, for an informative session designed to equip you with the knowledge and tools necessary to effectively handle quality deviations and audits. Attendees will gain valuable insights into developing robust investigation strategies that ensure compliance and improve overall quality management.
The presentation will cover key aspects of managing quality deviations, including identifying root causes, implementing corrective and preventive actions (CAPA), and documenting findings to meet regulatory requirements. By mastering these practices, your organization can better prepare for and respond to FDA inspections, minimizing the risk of non-compliance and enhancing operational efficiency.
This virtual event is essential for quality assurance, regulatory affairs, and compliance professionals in the pharmaceutical and medical device industries. By attending, participants will gain actionable insights from regulatory experts, helping them to proactively manage quality deviations and successfully navigate the increased inspection activity anticipated in the coming months.