Strong quality systems are required to maintain a successful business and avoid 483’s from FDA inspections. A common cause for citations in industry come from the management of quality events. Here are the basic elements in any quality event management process:

• Detection
• Categorization
• Root Cause Investigations
• Immediate Corrective Action
• Impact Assessment (quality and safety)
• Corrective and Preventative Actions
• Effectiveness Checks
• Closure, Trending, and Analysis

If you need help establishing a quality events management system, Pharmatech Associates can help! Contact us today to learn more.