A Review of the Top 10 - FDA 483 Observations and How You Can Avoid Them

The root cause of audit observations related to compliance can often be traced to faults in the execution of basic good practices. During this topic, we will review 10 of the most common audit observations and some of the contributing factors that can be managed to prevent their occurrence.

• Understand the practical critical effect of calibration and maintenance on and other good practices on compliance and risk
• Consider the balance of the complexity of GMP systems and processes versus effectiveness in avoiding 483 observations
• Consider modern approaches to managing GMP challenges that can simplify the approach

• A review of 10 of the most common audit observations during inspections    
• Reviewing common root causes for these types of observations based on the presenter’s experience in the field and how they contribute to the likelihood of an observation
• Methods to address the observed deficiencies that are scalable to small and mid-sized companies

The root causes of failures are often related to the basic organization and management of resources. Although the final failure gets the attention, often the root cause is actually at a more basic level that can be managed by attention to basic good practices. In this webinar, we demonstrate how many of the most common observations can be avoided.

Quality Assurance or Operations personnel may benefit by improving the impact of support services in their quality systems. Calibration, validation, and maintenance personnel may benefit from an additional understanding of available options and justification for resources that can have a real impact on operations and avoiding some common observations that may impact their departments.

Vince Sebald has 30 years’ experience working with FDA regulated companies in the areas of engineering, calibration, validation, maintenance, and general compliance. Vince, currently, works as a principal at Sebald Consulting and is CEO of GxPReady!, a company that provides GxPReady! Suite, a low-cost SaaS-based, 21 CFR 11 compliant CMMS solution for managing calibration, validation, and maintenance scheduling specifically intended to assist in achieving GMP compliance for small to mid-sized companies during their transition to GMP compliance. His experience in the above areas is shared as part of this presentation.