This module examines the importance of maintaining a safe and fully operational environment within manufacturing areas: Pharma Utilities, Facilities, HVACs and Cleanrooms. The online learning environment is designed to be educational, engaging, and above all, simple to use. A short assessment follows this module.
Learning Outcomes:
- Know the factors that affect facilities management, equipment and processes as applied in the pharmaceutical industry.
- Understand the layout of a typical pharmaceutical site.
- Roles and disciplines within facilities management.
- Deep understanding of HVAC systems; how they work, their components and how important they are to the proficient maintenance of quality and maintaining a sterile environment within manufacturing areas, especially in the pharmaceutical industry.
- An understanding of the intricacies of the equipment involved in providing a clean environment by being able to discuss the various filters involved in HVAC systems.
- HVAC systems standards and how they maintain a sterile environment not only within the manufacturing area but also in the products themselves.
- Be aware of simple factors which can have a dramatic effect on the quality of the work environment and the product that is being handled within it and measures taken to eliminate the risk of these incidents.
- Design and functionality of Cleanrooms; how critical the operations and maintenance of facilities, HVAC systems and Cleanroom behavior are to the pharmaceutical industry.
This Innopharma module is an overview of Tablet and Capsule manufacturing and packaging processes. Tablet's and capsules are the most common form of finished drug.
Learning Outcomes:
- Explain the basic steps and activities in drug discovery, development and clinical trials.
- List different pharmaceutical dosage forms
- Describe the different manufacturing processes for solid dose drug manufacturing
- Describe the typical manufacturing processes for Biopharmaceutical drug manufacturing
- Given a basic Process Map, identify the inputs, outputs and measures used to control drug quality
This module will examine bioprocessing for the production of products. A bioprocess is the application of natural or genetically manipulated whole cells, tissues and organs, for production. This online learning environment is designed to be educational, engaging, and is simple to use. An online assessment follows this module.
Learning Outcomes:
- An understanding of how bioprocessing is applied in the pharmaceutical industry.
- An overview of a typical bioprocessing environment
- How to work effectively in a cleanroom without causing a risk to the product.
- Furnish you with the science to succeed in the emerging technology-driven biotech industry.
- Understand the technologies in the biopharmaceutical industry, including the creation and manufacture of products that help in the diagnosis and treatment of disease (e.g. the production of antibiotics, insulin and recombinant proteins).
This module is an introduction to Quality Assurance and Good Manufacturing Practice. The short learning module is designed to give participants an overview of Good Manufacturing Practice (GMP) and the Quality System used in the manufacture of medicinal products. This online learning environment is designed to be educational, engaging, and above all, simple to use. When this course has been completed a short online assessment can be taken
Learning Outcomes:
- An understanding of Quality, regulatory bodies and regulations.
- Understand the purpose of the Pharmaceutical Quality Management System as well as a thorough knowledge of Quality System Elements. (QSEs)
- Understanding of each Quality System Element of QA, Premises and Equipment, Calibration, Technology transfer and training.
- Familiarity with the Quality System Elements in relation to Documentation, Supplier qualification and QC testing and stability.
- Knowledge of Quality System Elements of Validation, Change Control, Investigations and CAPA.