FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control 2011

Key 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.