Internal Audit should be a key part of self-awareness and understanding strengths and weaknesses within your Quality Management System. It should be an essential guide to corrective and preventive action and drive improvement. But it doesn’t always work that way. In this webinar, we’ll cover the reasons internal audit doesn’t work and how you can correct that. This webinar will explore how to improve your internal audit program, so it is an efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance and quality risks. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, many companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value-added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree.Learning ObjectiveFailures of internal auditRed flags indicating your program is not effectiveIdentify weaknesses in your internal audit programRisk Analysis techniquesAudit Program StructureImprovements for your Audit ProgramAreas CoveredRegulatory requirementsUsing a structured program to identify areas of risk leading to an effective audit strategyHow to develop a meaningful structure of audit, oversight, transparent communication, and escalation to management reviewHow to ensure your audit staff is well trained to proactively identify, communicate, and escalate issuesHow a culture of quality and compliance can encourage clear and transparent communication of riskHow to prioritize, resource, and implement corrective actionsTools for monitoring and communicating risk and improvement over time How to identify residual riskMonitoring and Controlling progress over timeSigns that your company culture is taking unnecessary compliance or quality riskHow to ensure management gets valuable information from your audit programHow to prioritize, resource, and implement corrective actionsTools for monitoring and communicating risk and improvement over time Who Should AttendQuality Systems SpecialistsDocument Control SpecialistsQuality and Compliance SpecialistsAuditorsAuditor ManagersSupplier AuditorsTraining SpecialistsCAPA SpecialistsQuality/Compliance managers or directors for Medical Device companiesGeneral Managers wanting to learn how to Management Review and expectations Why Should You AttendContinuous Improvement starts with an awareness of issues and opportunities. And without an effective internal audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight red-flags and ways to reduce compliance and quality risk.