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Deviation investigations and CAPAs are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations or ineffective CAPAs could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.
Objectives Of the Session:
Why Should you Attend:
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. 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.
Areas Covered in this Session:
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 – dos and don’ts
•Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
·Case Studies (deviations/OOS)
·Root Cause Tools (FMEA, Fishbone, Pareto, etc)
•Key Elements of the Investigation Report
Who will Benefit:
Site Quality Operations Managers
Quality Assurance personnel
Plant Managers and Supervisors
Manufacturing Superintendents and Managers
Regulatory Affairs Managers
QC Lab staff
Danielle DeLucy, MS, 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.