Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

Why Should You Attend:

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA continues to find fault with investigations and the stated conclusions. The FDA clearly expects that deviation investigations determine what happened, why it happened, and what was done to prevent it from happening again. Investigations also receive detailed scrutiny during FDA inspections. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Investigations are one of the key metrics that the FDA uses to assess the effectiveness of an organization’s Quality Systems. 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.

Most companies develop deviation investigation systems and SOPs to meet regulatory requirements and expectations. However, having good systems and procedures is not enough. It is the content and conclusions of the investigations themselves that truly count. Arriving at correct content and conclusions relies on good investigative technique, including interviews, fact/evidence gathering, and proper determination of root cause and CAPA. Therefore, it is important that investigators conduct each and every investigation in the same manner, and to the same standards with the emphasis on maintaining an effective quality system to assure product quality.

This webinar will help attendees understand the fundamental investigation steps and skill sets. Key focus will be placed on identification and initial reporting of deviations, product containment considerations, fact/evidence gathering, and arriving at the correct root cause and CAPA. The importance of investigation planning, critical thinking skills and avoidance of investigation bias will also be discussed.

Areas Covered in the Webinar:

• Overview of Regulatory Requirements for Investigations
• What is a Deviation?
• Types of Deviations/Identification of Deviations
• Deviation Investigation Process Model
• Immediate Containment/Immediate Impact
• Conducting the Investigation/Investigation Principles
• Interviews
• Source Documents/Evidence
• Determining Root Cause and CAPA
• Key Elements of the Investigation Report

Who Will Benefit:

• Deviation investigators
• Reviewers and approvers of deviation investigations (e.g. Dept. Heads, Quality Assurance)
• QA staff and management
• Regulatory Affairs staff and management
• QC staff and management
• Compliance auditors