Pharmaceutical Technology Transfer and Post Approval Changes

15/10/2018 - 16/10/2018

Pharmaceutical Technology Transfer and Post Approval Changes

 

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