FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control 2011 is a webinar that covers topics such as:
- 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
FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control brings together 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.
