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GMP Approval EMEA FDA Quality Management Medical Products ISO 13485 Sustainability Big Pharma Fermentation
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 assembly of technical documentations and gives advices forcompliant documentation structures required within quality management systems.Furthermore generation of stability data for identification of expiry dates is illustrated.
This seminar illustrates biosimilar production and its hazards. Examples from industry and necessities of compliance in biosimilar production are demonstrated.
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