PTI - international

• Validate processes in accordance with new regulatory requirements to avoid FDA enforcement actions
• Develop and implement validation master plans to establish a history of compliance and confirm a strategy for maintenance
• Determine when revalidation and requalification are required in order to prove reproducibility
• Monitor and control your validated processes to confirm uniformity and qualify variability
• Write a validation summary report in order to comply with FDA criteria for documentation
• Determine how much of validation and qualification is required by FDA to maintain both company efficiency and regulatory compliance
• Ensure the quality of your reported data by using scientific rationale and criteria when choosing critical validation parameters
• Apply statistical methods to determine validation parameters and qualify data
• Prepare for and manage inspectional observations by learning how to anticipate common FDA inspector trigger points
• Implement strategies for effective change control validation in order to establish sustainability
  

 Review the Course Brochure for Full, Detailed Information.

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 # 326-000-06-032-L04, Initial release: 07/2006.