Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

Product Id : FDA43
Instructor : Danielle DeLucy
Sep 14, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.

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. Ultimately, inadequate investigations can lead to negative 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. It is truly about “How You Do the Hows” day in and day out.

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.

Session Highlights:

  • 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 approves of deviation investigations
  • QA staff and management
  • Regulatory Affairs staff and management
  • QC staff and management
  • Compliance auditors

Speaker Profile:

Danielle DeLucy,is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

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