School of Pharmacy: Basic Pharmaceutical Development
Geared for professionals with non-science and business backgrounds to enter or advance in the pharmaceutical and related industries. Focuses on drug development project management issues.
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School of Pharmacy: Biopharmaceutical Manufacturing and Regulatory Affairs
The regulatory framework required for the approval of biotechnology-derived products (or biologics) is lengthy, rigorous and highly complicated. The Pharmaceutical Manufacturing and RA Certificate delves into the complex regulations governing the development, manufacturing and distribution of such products.
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School of Pharmacy: Clinical Trial Management
Provides tools and information needed to design, conduct and audit clinical trials of pharmaceuticals. The courses emphasize protocol development, volunteer informed consent, study management, and the role and responsibilities of institutional review boards.
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School of Pharmacy: Drug Development
Learn foundational knowledge and terminology helping industry maintain quality practices while meeting regulatory compliance at the local, national and global levels.
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School of Pharmacy: Food QA and RA
This certificate provides broad knowledge of the regulatory and quality practices of food and food medicines, helping those who work in nutritional products, food medicines and the food industry.
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School of Pharmacy: Global Pharmacovigilance (Benefit-risk Assessment)
The pharmaceutical industry is challenged with providing oversight of a drug’s safety throughout the product life cycle. Reviewing safety profiles and assessing benefit and risk that arise during and after drug development are rigorously explored.
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School of Pharmacy: GMPs for the 21st Century
This certificate provides a sound theoretical and hands-on approach to practices used in all of the critical stages of manufacturing. The overall goal is to enhance scientific understandings of manufacturing processes, standardizing product quality, improve plant efficiency and costs, and meet the new compliance requirements (both domestic and global).
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School of Pharmacy: Labeling, Advertising and Promotions
This certificate involves discussion of the complexity of the PI (package insert), showing how it must delineate every aspect of the product, from its dosage form to its unique storage requirements and dosage information. Topics include how the PI must be incorporated into print and internet advertising and promotions for products and discusses requirements of TV ads. Differences of regulations in key world markets are also discussed.
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School of Pharmacy: Medical Devices
This certificate enables students to receive specific training in the device field, receiving an overview of its domestic and global regulations. All courses provide hands-on application of regulations and quality practices.
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School of Pharmacy: Sterile Process Manufacturing
This certificate explores the routes and types of sterile product administration, manufacturing and facility requirements for their design and production, as well as validation and compliance specifications. Attention is also focused on the technical and regulatory aspects of sterilization processes, including thermal, gaseous, radiation, filtration and aseptic processing methods.
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School of Pharmacy: Validation Sciences
Validation is a critical and all-encompassing tool in the pharmaceutical, medical device, biotechnology and related regulated industries. At the heart of quality assurance practices, validation includes every test and scientific methodology used to demonstrate that facilities, utilities, equipment, processes, computers and products meet agreed-upon standards. Validation relies on the measured precision of scientific methods.
Learn more about Validation Sciences.