There are two main things which make returning for Open Programs such a valuable and worthwhile experience. The first is being back on campus – meeting the current students, returning to campus again, the whole experience was just so pleasant. The second is the level of quality in the courses – the faculty teaching are absolute experts.
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.
This course is offered in the part-time Master of Pharma Business Administration MBA program and may be attended on a “no credit” basis by individuals not enrolled in the program. Course participants are visitors who are not responsible for assignments and do not take an exam or earn academic credits. As the number of seats in the course is limited, we recommend to register online early.
Upon completion of this course, you will be able to:
- 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)
- Have 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
In order to achieve the goals of this course, you must master the following key concepts:
- Medical Affairs organizational evolution
- Late phase data generation formats, insight gathering tools and medical education spectrum as key value-generating medical pillars
- Relevant medical stakeholders and medical/scientific interactions
- Integrate the acquired knowledge to draft a medical launch plan.
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 (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.
Course materials will be provided in electronic form.
On Campus Westend of Goethe University Frankfurt and partially online via Zoom.
A GBS certificate of participation is awarded upon completion of the course.
€ 1,900 (fee is exempt from VAT). The fee for GBS students or alumni amounts to € 800.