This webinar will review the regulatory requirements for investigating an 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.
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.
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.
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 …
ChatGPT and Project Management: Leveraging AI for Project M…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Practice Safe Stress ™: Preventing Burnout While Building R…
Rewiring Your Emotional Triggers: Leading with Clarity and …
AI, Jobs, and Skills: How HR Leaders Can Prepare Now for th…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Writing Effective Job Descriptions
HR Metrics and Analytics 2026- Update on Strategic Planning…
High-Impact Performance Management: Tools, Tactics & Coachi…
Validation Statistics for Non-Statisticians
Batch Record Review and Product Release
Human Factors Usability Studies Following ISO 62366 and FDA…
Best Practices for FDA Computer System Audit Preparation in…
Fire Without Fear: How to Legally Terminate an Employee
FDA Regulation of Artificial Intelligence/ Machine Learning
Empowering Conflict Resolution: Letting Go to Gain Control
The Importance of the first 5 seconds when presenting
Burnout to Fired-up : Recognizing and Preventing Burnout in…
Do's and Don'ts of Giving Effective Feedback for Performanc…
Managing Toxic & Other Employees Who Have Attitude Issues
Reduce Stress in the Workplace: Effective Ways to Handle Co…
Better Mind, Better Life: Unlocking Your Full Potential
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Why EBITDA Doesn't Spell Cash Flow and What Does?
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Human Error Trends as AI Enters GMP Operations: What QA Lea…