Course description
Process Development and Production of API
An understanding of chemical development and the particular challenges during each phase is the primary focus of this course. A combination of theory and practice using fresh examples from industry and the literature will create the foundation for solid decision-making skills and an understanding of the trade terminology.
The development of a safe and efficient manufacturing process of an active pharmaceutical ingredient (API) or bulk drug substance is a substantial undertaking. A successful endeavour requires solving problems within synthetic organic, bioorganic, physical organic, analytical and environmental chemistry, engineering, and economics.
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Upcoming start dates
Suitability - Who should attend?
If you wish to learn how you efficiently produce a new medicine this is the course for you. You may have occasional or more regular contact with producers or departments working with process development, or even wish to enter the field yourself, and therefore would like to know more about how this work is performed. Attending this course will give you a good insight in the processes, regulations and options for the production of both small molecule and biopharmaceutical drugs.
Participants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Be proficient in English
Training Course Content
- Upon completion of this course you will be familiar with the terms, principles and methods used in developing a chemical process from discovery to routine manufacturing.
- You will be able to discuss different aspects and solutions to problems in a broad range covering scale-up, organization, planning, process monitoring, validation, life cycle management, registration, resource consumption, environmental and safety issues.
- You will be able to closely interact with specialists and work as project leader where process development is a part of the project.
- You will have learned how to identify and explain common risks and problems in process development.
- You will be able to compute and critically apply various process metrics.
Course delivery details
We have assembled a unique team of industrial speakers who are experts in process development and production of pharmaceutical ingredients. The course will cover both the theoretic background and give an industrial perspective on modern drug production and regulations.
Expenses
Course fee
- DKK 12,900 for EU/EEA citizens
- DKK 14,985 for non-EU/EEA citizens