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
