PTI - international

Improve Your Ability to:

• Validate computer and software systems and save money by discovering defects prior to production
• Determine what needs to be validated and how much validation is enough to ensure regulatory requirements are met
• Address FDA expectations for legacy systems and off-the-shelf software and avoid costly regulatory consequences
• Re-format database and ensure data is compatible with a new environment
• Create and execute a master validation plan to define the performance requirements of your system
• Generate and maintain adequate IQ/OQ/PQ documentation
• Audit software vendors effectively and efficiently to avoid integrating deficiencies of outside work
• Implement proven solutions for issues such as data integrity and security, document traceability and change control and create an easily navigated system
• Anticipate FDA field investigators' hot button issues and avoid regulatory enforcement actions
  

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 # 326-000-06-023-L04, Initial release: 07/2006.