Development of Generics: From R&D to GMP MasterClass

  • 10-11 May 2021
  • Online Event

Description

The Development of Generics: From R&D to GMP MasterClass covers topics such as:

  • 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

The Development of Generics: From R&D to GMP MasterClass brings together:

  • 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

The Development of Generics: From R&D to GMP MasterClass will be held on 10-11 May 2021.

More Details

Organizer:
GLC - Global Leading Conferences
Website:

Future Events

  • Development of Generics: From R&D to GMP MasterClass - 10-11 May 2021 (92574)
  • Development of Generics: From R&D to GMP MasterClass 2022

Important

Please, check the official event website for possible changes, before making any traveling arrangements

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