One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations, Root Cause analysis, CAPA & risk assessment. The FDA uses the investigation reports and investigation trends to identify potential quality problems and action plan taken in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required.

Having a procedure on investigations, Root Cause analysis, CAPA & risk assessment is not enough. It is the strategy, content, extent of efforts made and final conclusions that truly count.

This seminar will help attendees understand the fundamental steps, practical approach towards investigations, Root Cause analysis, CAPA and proactive approach as well as reactive approach of risk assessment.

Key focus will be put on practical examples, implementation & compliance practices with respect to current guideline requirements, FDA citations and learning from observations.