PRODUCTION & QUALITY MANAGEMENT

The “Production” part of the course will make students familiar with the key elements & concepts of pharmaceutical manufacturing. It includes key aspects of supporting functions such as quality, engineering, HSE, supply chain management, logistics, finance & project management as well. Finally, the importance of an experience / well-trained staff as well as leadership tools will be introduced.

The “Quality Management” part of the course will introduce students to major aspects of the management tools for Quality Management with focus on the pathway for digital transformation to “Pharma 4.0” as the next industry level. The sessions will provide a working knowledge for attendees to understand requirements resulting from stakeholder needs, legal requirements and global guidelines along the pharmaceutical product life cycle. Implementation in day-to-day work and the demand of competencies and skills for Quality Management and interaction with all partners will be discussed.

Topics covered in the course will focus on a holistic few and interaction with stakeholders of Pharmaceutical Manufacturing and the role of Quality Management within the life cycle of a medicinal product (R&D, Regulatory Approval, Technology Transfer, Production, Quality Control, Release, Pharmacovigilance, Change Control and Continuous Improvement) and the pathway to digital transformation and digital maturity.