PTI - international

• Respond effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventive actions
• Save time and effort by determining which complaints must pass through a CAPA program
• Verify and validate a CAPA program to ensure problems are permanently fixed and corrections are carried out
• Create an safe and regulatory compliant manufacturing setting by Integrating RCA with internal auditing, CAPA and complaint handling
• Gather, organize and manage the data required to conduct enlightening RCA and carry out thorough investigations
• Perform trend analysis and use effective RCA tools (Flow Charting, Fault Tree Analysis, Fishbone Diagrams, etc.)
• Optimize CAPA and RCA documentation procedures to create traceable steps for FDA inspections 
• Analyze FDA Warning Letters and common citations to avoid non-compliance
• Communicate key CAPA issues to management to establish positive team interaction
  

PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-04-112-L04, Initial release: 10/2004.