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The 50 plus years since the structure of DNA was solved have been punctuated by spectacular advances both in our understanding of biological processes and in the very methods developed to achieve this understanding.
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This introductory course provides an overview of key drug quality concepts and standards for the pharmaceutical and biotechnology industries. Interactive lectures explore quality system and control process best practices in clinical development, drug manufacturing and for commercial products. You'll learn the roles and responsibilities of quality assurance (QA) and quality control (QC) in ensuring the safety, efficacy and quality of drug products. You'll contrast specific quality attributes of large-molecule recombinant biological products with those of small molecule drugs.
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|BTEC.X401||Drug Development Process|
|REGL.X400||Good Manufacturing Practices|
|REGL.X403||Regulation of Drugs and Biologics|
This course covers biochemistry concepts central to the biotechnology industry with an emphasis on the enzymatic and metabolic processes of living systems at the molecular level. Topics include the structure and function of biomolecules including proteins, carbohydrates, lipids and nucleic acids; enzymes and enzyme kinetics; and metabolism, including energy production and storage.
Many companies in the healthcare and bioscience industries utilize Protected Health Information (PHI) or Personally Identifiable Information (PII) to develop and test products such as medical devices and mobile applications, or to perform other services, including data analysis, on their customer’s healthcare related data. This course examines the important data privacy and security issues that govern these industries.
Recent advances in stem cell biology and cancer research illustrate the importance of understanding complex biological processes at the cellular level. This course covers the essential concepts of cellular biology, including the functions of cellular macromolecules, subcellular organization, nuclear control of cellular activity, cell signaling and cancer. You'll also learn the experimental approaches used to explore cellular activities.
Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.
Well-planned and well-executed clinical trials are the cornerstones of effective drug and medical device development. Offered in an accelerated format and taught by leaders in the biopharmaceutical industry, this course provides a unique opportunity for professionals from all disciplines to learn about the many facets of clinical trials--the complex process that ensures the safety and effectiveness of medical products.
Immunology involves a complex network of interacting molecules and cells that function to recognize and respond to foreign agents. It also has wide-ranging implications for the pharmaceutical, healthcare and biotechnology industries. This course provides the fundamental principles of immunology, along with recent developments and their implications for drug discovery and development, as well as disease treatment.
Knowledge of how gene expression is regulated is essential to understanding cellular structure and function, both in normal cells and in the disease state.
DNA microarrays, also known as DNA or gene chips, have revolutionized the field of molecular biology. They provide the ability to quickly and efficiently analyze complex biological processes. As a result, they play a leading role in the discovery of new biopharmaceuticals.