AUDIT LIKE THE FDA - EFFECTIVE INTERNAL AUDIT PROGRAM
July 20 - 21, 2023 - CAEventura World
info@eventura.us
Phone:+1-416-915-4438
This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. 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. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, estimates indicate that up to 75% of 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. A well planned audit program can reduce these risks. Continuous Improvement starts with awareness of issues and opportunities. And without an effective 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. WHAT WILL BE DISCUSSED: Regulatory Expectations How to develop and implement an efficient and effective audit program Common problems Red-flags that your program is not effective Risk Analysis techniques Audit Program Structure The auditing process – steps and tools Documentation and communication Linkages within your Quality System to ensure audits lead to effective solutions and lasting improvement