PTI - international

• Create an easily read paper trail by properly documenting all aspects of failure investigations process deviations
• Comprehend the scope of FDA guidance for failure investigations and avoid regulatory issues
• Distinguish appropriate tone and wording for the report to enhance readability and technical quality of your documents
• Recognize view points of all departments in a failure investigation and boost departmental communication and investigation quality 
• Effectively capture and document facts and root causes to best conduct more thorough and complete investigations
• Implement appropriate corrective and preventive actions (CAPA) to display permanent solutions to failures and process deviations
• Generate documented evidence that failures are investigated and appropriate actions are taken to better address any concerns about your process
• Clearly convey your investigation process by structuring an effective and traceable summary report
• Audit your investigation system to ensure the system is always operating at the highest level
• Create and modify multiple accident reports so that thorough and complete reports are provided to FDA

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 # 326-000-06-058-L04, Initial release: 07/2006.