This Innopharma Module is on Medical Devices, which is a significant and growing global industry. Devices can range from a single band-aid to an MRI scanner. Medical devices are designed and manufactured, subject to regulation regardless of their simplicity or complexity. This module looks at these processes and the importance of good manufacturing practice. This online learning environment is designed to be educational engaging and above all simple to use. When this module is completed, an online assessment follows.
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.
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 is an introduction to Process Analytical Technologies (PAT).
Learning Outcomes:
- Introduction to Quality by Design
- Introduction to Process Analytical Technology
- PAT Regulations
- The Reasons for PAT
- The Implementation of PAT
- PAT Technologies
- Real-Time release and Impact to Quality Systems
- Benefits of PAT
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 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 course is designed to give you an overview of Validation Master Planning and the Validation of systems & processes. This online learning environment is designed to be educational, engaging, and above all, simple to use. A short online assessment follows the module.
Learning Outcomes:
- Why we validate and the Regulatory requirements surrounding the manufacture of medicinal products.
- Validation master planning and documentation
- GMP facility, equipment and utility qualification
- Validation design, verification and qualification
- Process validation
- Cleaning Validation
- Pharma GMPs for the 21st century
- Post validation activities and maintaining the validation status
This Innopharma module examines the process of clinical research and its importance to researchers, regulators and, patients. After this module, a short online assessment follows.
Learning Outcomes:
- Map the process of clinical research, its importance to the researchers, the regulators, trial subjects and ultimately those who use the drug and therapies – the Patient
- Understand the key factors which affect the $1 trillion + industry today and the current trends which influence its rapid development and growth.
- Be able to discuss the different treatments which are constantly being developed and improved to fight common conditions such as heart disease, stroke and cancers. Become familiar with Drug therapy areas including allergy and immunology , cardiovascular and metabolic disorders, neuroscience treatments, infectious disease treatment, oncology and vaccines.
- Be able to walk through the processes of Drug Discovery and Drug Development.
- Understand in detail the process of pre-clinical and clinical trials, the role of regulatory authorities in testing and assessment of quality, efficacy and safety of drugs.
- Clear understanding of Pharmacovigilance and its role in the detection, assessment, understanding and prevention of adverse effects. Members of the academy will learn of its reach to herbs, traditional and complementary medicines, blood products, biological, medical devices and vaccines.
- Regulations and Ethics of getting drug therapies to the market and their relevance to patient safety.