Best Practices for Investigating Deviations
Danielle DeLucy, MS, is the 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.
One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. 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 483 citations, Warning Letters, a release of the sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required. Having a procedure on Deviation Investigations is not enough. It is the content and conclusions of the investigations themselves that truly count. Doing a proper root cause analysis, gathering evidence and ensuring a sustainable corrective action is a key to a proper deviation investigation. This webinar will help attendees understand the fundamental investigation steps and skill sets. A key focus will be placed on identification and initial reporting of deviations, fact/evidence gathering, and arriving at the correct root cause and CAPA. The importance of investigation planning, critical thinking skills, and effective preventative action plans will also be discussed.
This webinar will help attendees understand the fundamental steps of a deviation investigation with a focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.
- Review of FDA and Regulatory Requirements for Investigations
- What is the definition of a Deviation?
- Types of Deviations/Identification of Deviations
- Conducting the Investigation
- Interviews – do's and don’ts
- Source Documents/Evidence
- Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
- Key Elements of the Investigation Report
Who Should Attend
- Compliance auditors
- QC staff and management
- Regulatory Affairs staff and management
- QA staff and management
- Reviewers and approvers of deviation investigations
- Deviation investigators