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Training Overview

From the idea to the patient
Since 1231, when Friederich II passed the Constitutione Regni Siciliae, (the first medicinal
law for Europe) the regulations for medicinal products have changed. The first chemically synthesized APIs in combination with the industrialization beginning 1900, shifted the production of medicinal products from pharmacies to pharmaceutical companies. Meanwhile we have a big variety of laws, regulations and guideline, which accompany the different phases of the approximately 12 year from the first idea until a new medicinal product is available for the patient. This seminar want’s to give an overview of the relevant good working practices and provides the connection to the life cycle of a medicinal product. The main focus here is on the Good development practice, Good Manufacturing Practice
and Good Distribution Practice in combination with the life cycle of a Medicinal Products.

Learning Outcomes:

• Overview of good practices in the pharmaceutical indusry
• Law, guidelines and regulations
• Responsibility of the management in GxP
• Roles and responsibilities of the quality functions
• Risk managment and risk based approach
• Definitions quality by design, total quality
• ISO 9001 and GMP
• Continuous process improvement (CAPA)
• How to handle inspections and audits

Who should attend?

• Upper management
• Head of Production/group leads/manager
• Head of QC/ group leads/ manager
• Head of QA/group leads/manager
• Head of quality/manager                                                                                                       As well as those who are interested in quality & supply chain or distribution.


Ute Reichert
Ute ReichertConsultant in Pharmaceutical Industry

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Request detailed Agenda - GxP in Pharma MasterClass