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GMP EMEA Approval Medical Products FDA Quality Management Business to Business ISO 9001 Solid and Liquid Formulations Approval of Medical Products
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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