Reference material for easy implementation:

• SOP: Handling OOS results
  
• SOP; Laboratory Failure Investigations
  
• Checklist: Handling OOS Results
  
• Case studies: How to Avoid 483s and Warning Letters Related to OOS and Failure Investigations

Areas Covered in the Session:

• FDA and international regulations and guidelines
  
• FDA's Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
  
• Most recent OOS related FDA 483's and warning letters
  
• Requirements of ICH Q7A for APIs
  
• Developing an effective SOP for OOS situations and laboratory failure investigations
  
• Managing formal and informal investigations in laboratories and manufacturing
  
• Efficient use of checklists and forms
  
• Compliant handling of retests
  
• Retesting: what, when and how many times
  
• Developing corrective and preventive action plans
  
• Strategies to avoid OOS situations BEFORE they occur
  
• FDA compliant documentation of OOS, failures investigations and root causes

Who will benefit:

• Laboratory managers and supervisors
  
• GMP auditors
  
• QA/QC managers and personnel
  
• Qualified persons (for EU compliance)
  
• Analysts and other laboratory staff
  
• Regulatory affairs
  
• Human resources (HR) managers and staff
  
• Training departments
  
• Consultants