PTI - international

• Comply with APR requirements set forth in 21 CFR 211.180(e) and avoid regulatory action
• Interpret the FDA's unwritten expectations to ensure inclusion of appropriate, high quality data in the APR
• Maximize the APR's effectiveness as a quality improvement tool to enhance overall quality of your product and process 
• Avoid end-of-year crunch time by implementing a more efficient APR process
• Employ statistical analysis techniques to assess trends and manufacturing process efficiency
• Use the APR to capture a higher view of your data and help determine the need for revalidation and confirm change control  
• Ensure compliance with documentation requirements to enhance preparedness for an inspection of your facility
• Develop and/or refine SOPs to enhance effectiveness and compliance
• Utilize CAPA and an effective team approach to save valuable time and avoid duplicated efforts
• Write Annual Reports (ARs) to meet NDA requirements and understand  the link between APRs and AR requirements
• Compare EU requirements for Product Quality Reviews to the FDA's AR requirements 

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 # 326-000-07-078-L04, Initial release: 01/2007.