Developing a new medical device for commercialization is a complex process. The FDA has guidelines that provide a framework for designing and manufacturing medical devices. This course will provide a detailed and practical overview of the design control…
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Within you there dwells an innate sense of storytelling and a unique voice with which to tell your stories. In this course you will explore writing techniques to help you locate and refine the "natural music" of your own voice. Through writing exercises and…
The cornerstone in the efficient manufacturing of a medical device is the implementation of a quality management system. Medical Device companies are required to develop a QMS that conforms to the regulations imposed by the FDA and ISO 13485 to ensure the…
This course reviews the breadth of U.S. and international regulations associated with the development of drugs, biologics, medical devices, and diagnostics. Topics include a review of regulatory agencies and the role/responsibilities of each; pathways for…
With the growing amount of data available to businesses, decision-makers must translate strategy into accountability, measure progress against goals, and leverage data for business decision making. Dashboards are used to present and analyzing enterprise…
This introductory course provides a comprehensive overview of the drug development process, from initial development through regulatory approval and commercialization. The course emphasizes the role of regulatory agencies such as the U.S. Food and Drug…
This course provides a comprehensive overview of the regulatory pathways and submission processes for drugs and biologics from early development through market approval. Students will learn to prepare and submit Investigational New Drug (IND) applications,…
This course examines the principles that regulate the process of proving facts at trial. Until recent years, the regulating rules were found in the traditions of the common law. Many jurisdictions now codify the law of evidence, and consequently the course…
The Employer Sponsored Induction Individualized Learning Plan (ILP) provides candidates admitted to the Induction program with an overview of the entire program, including its scope, goals, expectations, requirements, standards, and competencies.Through…
The Employer Sponsored Induction Individualized Learning Plan (ILP) provides candidates admitted to the Induction program with an overview of the entire program, including its scope, goals, expectations, requirements, standards, and competencies.Through…
French I provides an initiation to conversational French, covering chapiters 1-3 of the textbook. Accordingly, its main goal is to equip students with simple, yet effective tools for handling simple interactions with French speakers. These tools include…
Master the essential principles and practices of validation and qualification in the pharmaceutical industry with our comprehensive 10-week course, designed to equip you with the skills needed to ensure compliance, product quality, and regulatory excellence.
The way the business world uses Excel is constantly evolving. Keeping up with these changes can be intimidating, complex, and confusing, given Excel’s ever-expanding library of functions and features. The Advanced Excel for Analysis and Business Intelligence…
This course focuses on effective collaboration and communication skills for members of young learner’s support team. This team includes teacher and staff, significant family members, service providers, health practitioners, as well as community partners,…
Technical Communication I 10 weeks | Online This is a practical, hands-on technical writing course for all currently practicing or would-be technical communicators wishing to get a firmer grasp on this extremely broad and quickly evolving industry and develop…
Writing Online Documentation 10 weeks | Online As more print publications and manuals go online, it's vital to understand the similarities and differences between writing for print and writing for online delivery. Explore theories and practices for creating…
We will cover chapters 4, 5, and 6 in the textbook, continuing where we left off in French 1. We will continue to study the present-tense conjugation; we will add a few new verbs to the list of irregular ones you already know, and will widen our focus from…
Textbook chapters 6-8. Includes an in-depth study of French articles, continued work in the present tense, learning to describe one's memories and describe the way things used to be ( imparfait ), and an examination into the subtleties of the past tense (the…
GXP audits and inspections are conducted to identify non-compliances, but also regulatory weaknesses and the potential for non-compliance. This course introduces students to GXP audits and inspections, including internal audits/self-inspections, external…
Review current genomic sequencing technologies while exploring the scientific and medical applications that these technologies are enabling. We will cover traditional and modern sequencing platforms, new technologies for dissecting genetics and epigenetics…
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The Course Register brings continuing, professional, and extension education from 8 American research universities into one searchable, exportable index — covering 3,570 searchable upcoming courses across 27 subject areas. Every listing is mirrored from the university's own catalog and links back to the issuing source, so dates, tuition, and availability can always be verified at the origin.
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