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Events Course Topics Include:
• Current Status of Technology Transferand Post-Approval Changes
• Analytical Methods and Quality ControlSpecification Transfers
• Dosage Forms Transfers
• Internal and Third Party Transfers
• Packaging Components and Process Transfers
• FDA Guidelines for Post-Approval Changes (SUPAC) & Transfers
• Post Approval Changes (labeling, packaging, manufacturing site, API, process)
• FDA Recommended Data to SupportPost approval Changes
• New Emerging Trends In Post ApprovalChanges & Transfers Worldwide
• Interactive Case Studies
To be presented at:
Parc Cientific de Barcelona
Baldiri Reixac 10
08028 Barcelona, Spain
For complete course information see Course brochure,
call: +34 934487156
or e-mail: info@sitec pharmabio.com
