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 seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.
Areas Covered in the Session :
- 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
Who Should Attend:
- Quality Assurance Departments
- Analysts and Lab Managers
- CAPA Management Departments
- Regulatory Affairs Departments
- Training Departments
Course Director: 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 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.