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GMP Approval EMEA Medical Products FDA Quality Management Lean Managemment Classification by Risk Potential Generics FMEA
This seminar deals with current regulatory affairs in Good Manufacturing Practice directedby US agency FDA. Relevant guidelines for compliance and documentation requirements for development and production are illustrated.
This seminar deals with validation parameters and its determination in accordance to current directives. Also GMP validation procedure and software validation is demonstrated.
This seminar deals with current strategies of formulation development. Here case studies for therapeutic agents from different leading companies will show that there is no perfectrecipe for an optimal formulation.
This seminar ilustrates setup of GMP compliance for mRNA vaccine production. EMA / FDA registration and GMP inspections by German authorities.
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