This webinar with expert Danielle DeLucy will review the regulatory requirements for investigating an Out -of-Specification or OOS Investigation.
The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Session Highlights:
FDA requirements for handling OOS/ OOT results
Phase I- Laboratory Phase of Investigations
Phase II a Full-Scale Investigation
Concluding an Investigation
Out-of-Trend investigations
Common pitfalls during OOS Investigations
Review of recent OOS related citations in Warning Letters
Why You Should Attend:
The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
Most companies have procedures but either they are not adequate or are not followed. This webinar will guide attendees through the entire process from the detection of an out-of-specification result to the informal and formal laboratory and batch investigations.
Who Should Attend:
Quality Assurance/Quality Control Directors, Managers, and Specialists
Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
Quality Control Laboratory Staff
CAPA Managers and Coordinators
Danielle Delucy
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 17 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.