Development of Generics: From R&D to GMP MasterClass

Topics

• Building the GMP fundament
• Legal basis for Generics, Hybrid Products, Biosimilars
• Revision of Environmental Risk Assessment
• Procedures to Marketing Authorisation
• How the analytical methods should be described in the CMC dossier and in GMP documents
• How Quality by Design development can be implemented
• The importance of a well-structured pharmaceutical life-cycle management
• How to deal with more recent requirements concerning Elemental Impurities or N-Nitrosamines in CMC or GMP

Who should Attend

• Manufacturing Heads
• Heads of R&D
• Heads of QA
• Heads of QC
• Manufacturing managers
• Pharmaceutical Development managers
• QC managers
• Stability control managers
• Product Maintenance managers
• Drug Regulatory Affairs managers