Topics
- FDA`s final Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA regulations and guidelines
- Developing SOPs for OOT situations and laboratory failures
- Difference between OOS and OOT results
- Retesting of OOT results
- Investigating OOT results: what and how
- Using QC samples and product control charts for evaluation
- Using historical data for OOT evaluation
- Finding the root cause for OOT results
- Developing corrective and preventive action plans
- FDA compliant documentation of OOS, OOT, failure investigations, root causes and CAPA
- Strategies to avoid OOS situations BEFORE they occur
- Examples: different types of case studies
Who should Attend
GMP auditors, Laboratory managers and supervisors, Qualified persons (for EU compliance), QA/QC managers and personnel, Regulatory affairs, Analysts and other laboratory staff, Training departments, Human resources (HR) managers and staff and Consultants.
