The "Production" course content introduces students to key concepts of pharmaceutical manufacturing, covering essential support functions such as quality, engineering, HSE, supply chain management, logistics, finance, and project management. It also emphasizes the importance of experienced, well-trained staff and leadership tools. The "Quality Management" content focuses on key aspects of Quality Management tools, particularly digital transformation toward "Pharma 4.0." Students will gain a working knowledge of stakeholders' requirements, legal obligations, and global guidelines throughout the pharmaceutical product life cycle. The course discusses implementation in daily operations, required competencies, and interactions with all partners.
The course topics will center on a holistic view of Pharmaceutical Manufacturing, the role of Quality Management across the medicinal product life cycle (including R&D, Regulatory Approval, Technology Transfer, Production, Quality Control, Release, Pharmacovigilance, Change Control, and Continuous Improvement), and the journey to digital transformation and maturity.
- Understand the importance of manufacturing and an efficient supply chain for the pharmaceutical industry & the patients
- Judge the proper implementation and execution of GMP- processes and its impact on the quality & safety of pharmaceutical products
- Assess the value of cross functional cooperation & leadership for production
- Built stronger bonds with manufacturing within your area of responsibility
- Understand the role of Quality Management and essential Quality Assurance requirements resulting from global / local laws and guidelines
- Interact as a skilled partner with Quality representatives and stakeholders (internal customers, competent supervisory authority representatives)
- Retain a sound knowledge on Risk Management process and its importance for the Quality process
- Improve pharmaceutical industries quality level through a holistic view of Quality Management and provide the pathway for digital transformation to Pharma 4.0
This course is part of the prestigious part-time Pharma MBA program, conducted in English on Fridays and Saturdays on Campus Westend. It offers a valuable opportunity to network and gain expertise without committing to a full degree program. As the number of seats is limited, we recommend to register early. If you’re a GBS alumni, explore our attractive alumni discount options.
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Participants have the choice of completing the course with a qualified certificate or attending as a guest auditor. As an auditor, you are not required to complete assignments, take exams or earn academic credits.
| ECTS | Certificate | |
|---|---|---|
| Guest auditor | - | Certificate of Participation |
| Full participant | 5 CP | Qualified Certificate |
Dr. Christian Matschke
Dr. Christian Matschke (MSc in pharmacy, Ph.D. in pharmaceutical technology, BBA) has 20 years of experience in pharmaceutical development, production, quality, SCM & general management. He successfully led global projects, production sites and larger TechOps organizations in Germany, Poland, Switzerland, India and Austria. Today, Christian serves as a member of the board in Berlin-Chemie AG (a Menarini company).
Dr. Hans-Martin Schwarm
Dr. Hans-Martin Schwarm (Ph.D., Licensed Pharmacist, and Certified Food Chemist) has over 30 years of experience in Pharmaceutical Industry at various positions on senior and corporate management level for Quality Assurance and Quality Management, Regulatory, Product Development and Technology Transfer. He was also responsible for international projects in Europe, US, India, and China. Today, he is Senior Advisor for Pharma and Health Care.
| Date | Session |
|---|---|
| Fri., November 8, 2024 | 13:00-15:00; 15:30-17:30; 18:00-20:00 |
| Sat., November 9, 2024 | 09:00-11:00; 11:30-13:30; 14:30-16:30 |
| Fri., November 22, 2024 | 13:00-15:00; 15:30-17:30; 18:00-20:00 |
| Sat., November 23, 2024 | 09:00-11:00; 11:30-13:30; 14:30-16:30 |