PTI - international

• Meet the FDA's expectations for GxP documentation to avoid regulatory action
• Write concise, approvable documents by learning how to identify and avoid common documentation errors
• Apply proven writing techniques for essential GxP documents to ensure they are clear and user-friendly
• Accelerate document review and approval processes to speed overall product approval
• Implement efficient document migration and archiving practices to create a traceable document trail
• Conduct effective audits of GxP documentation to identify and correct common pitfalls
• Implement best practices for Electronic Data Management (EDM) and 21 CFR Part 11 compliance to facilitate the move to a "paperless" environment
• Determine document review frequency by applying risk management methodologies to GxP documentation practices

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 # 326-000-06-056-L04, Initial release: 07/2006.