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Certified Six Sigma Black Belt, has more than 12 years of experience working with high-tech industry leaders such as Intel, SAP, and HP. Mr. Dave specializes in global program and portfolio management in supply chain development, ERP (SAP R/3), enterprise information systems, new product introductions, emerging technologies, and Lean Six Sigma projects.
PMP® is a registered mark of Project Management Institute, Inc.
|Qualifications||M.S., M.B.A, PgMP®|
Consider what it takes to create a safe, effective, high quality pharmaceutical product that complies with global International Conference on Harmonization (ICH) Quality Guidelines. In this course, students review each guideline pertinent to drug development, patient safety, health authority review, and commercial manufacturing. This uniquely robust overview provides an understanding of the regulatory intent, helping to prepare professionals for competitive job roles in San Francisco Bay Area biopharma.
High-throughput efforts by biopharmaceutical companies focusing on the discovery and validation of new targets and identifying agents that affect them will uncover a multitude of new chemical and biological agents that have the potential for clinical benefits. However, before such agents can be tested and used widely in patients, safety and acceptable toxicity to critical organs must be demonstrated.
This course surveys the adverse effects resulting from the interaction of chemical agents with living systems.
California is at the forefront of stem cell research and the industry continues to offer exciting opportunities in the Bay Area. This introduction to stem cells and their applications is geared towards professionals in the pharmaceutical, biotech, medical device, and healthcare industries. It addresses the basic biology and clinical applications of embryonic and adult stem cell therapies, provides a market overview of stem cell startup companies, and touches on the FDA regulation of biologic products.
Rapid advancements in molecular diagnostics are drawing the attention of the bioscience industry, regulatory agencies, clinicians, patients and insurers alike. This survey course provides a foundation in the basic science and technologies that underlie the emerging field of molecular diagnostics, and highlights potential impacts on the healthcare landscape.
Interactive lectures explore the intricate relationship between the human genome and diagnostic tests.
This course introduces the fundamental principles of human physiology in health and disease, and provides insight into emerging and established therapies used to treat a range of disease processes. Designed for individuals who lack formal medical training, the course introduces the hierarchical organization of the body, from cells to coordinated organ systems, and continues with a discussion of the key integrative/homeostatic control mechanisms.
Understanding the molecular and cellular basis of cancer is essential for the development of new therapeutic strategies and diagnostic tools. This course explores the basic biology of cancer, including the key cellular processes and players, whose alteration leads to uncontrolled cell proliferation. Topics include the pathology and genetic basis of cancer, the immune system, and the role of infectious agents and environmental carcinogens in the disease process. You'll also discuss emerging therapies and strategies for cancer prevention.
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This course explores the fundamentals of statistical methods and reasoning. Topics include descriptive methods, data gathering, probability, interval estimation, significance tests, one- and two-sample problems, categorical data analysis, correlation and regression. The instructor will demonstrate the use of spreadsheets and statistical software to analyze and interpret data. Examples are drawn from a variety of fields including biology, business and marketing. While not too mathematically rigorous for the novice, the course provides some mathematical detail to illustrate basic concepts.
The recent outbreaks of Zika and Ebola viruses and an increase in the rates of certain viral infections reflect the profound impact viruses have on human health worldwide. Students in the course study past viral pandemics—influenza, smallpox, and polio—and how they have altered human history. They survey how viruses replicate in human hosts and spread in human populations. Students also learn how recent developments in molecular biology and genetics have been instrumental to the biopharmaceutical industry in developing antiviral drugs and viral vaccines.