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Course Criteria
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3.00 Credits
Banner Title: Regulatory Affairs Compliance This course is an introduction to regulatory agencies and the role of cGMP compliance in manufacturing of drugs, biologics and medical devices. The course initially explores the role of governmental oversight and regulation, particularly by the FDA, during the discovery, development and manufacturing of new products produced by the pharmaceutical and biotechnological industries. Benchmark Congressional Acts (e.g. the Food, Drug and Cosmetic Act) are studied while describing the evolution of the FDA to its present state. Case studies are emphasized. Students are introduced to facilities and processes used in the manufacture and packaging of pharmaceuticals (drugs and biologics) and medical devices. Thus studied are facility design, monitoring systems, cleaning and sterilization, clean room environments, and fill and packaging operations. The course emphasizes how good documentation practices assure the quality and safety of a product as the manufacturing process moves a product down the production pipeline. Prerequisite: Program admission Offered on an as-needed basis for the associate degree program in Biopharmaceutical Manufacturing Technology and the Quality Assurance and Validation Technician technical certificate of credit
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3.00 Credits
Banner Title: Quality Assurance/Validation This course provides information on quality assurance and validation principles and applications in the biotechnology, biopharmaceutical, and medical device industries. Instructors emphasize manufacturing processes, specific dosage forms, FDA rationale, and documentation requirements. Prerequisite: BIO 221 Offered on an as-needed basis for the Quality Assurance and Validation Technician technical certificate of credit
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4.00 Credits
Banner Title: Patents and Technology Transfer Students are introduced to the role of patents, one type of intellectual property, in advancing technological innovation and promoting economic development. The requirements for the issue of a patent are described together with the legal rights that are thereby conferred to the patent holder. Topics include the preparation of the patent application and its filing with, and examination by, the United States Patent and Trademark Office (USPTO). The course explores how the patented invention may be commercialized in the process of technology transfer. Emphasis is placed on the patenting and transfer of technologies pertinent to the biotechnology, pharmaceutical, and medical device industries. Prerequisite: BIO 221 Offered on an as-needed basis for the Quality Assurance and Validation Technician technical certificate of credit
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5.00 Credits
Banner Title: Beginning Document Processing Instructors introduce students to the touch system of keyboarding by placing emphasis on correct techniques, mastery of the keyboard, and basic business documents. Students attain a minimum typing speed of 35 gross words per minute with a maximum of 3 errors on a 3-minute timed test. Topics include learning the keyboard, building speed and accuracy, formatting basic business documents, language arts, and proofreading. Prerequisite: Provisional admission Offered quarterly
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5.00 Credits
Banner Title: Intermed Document Processing Students continue to develop keyboarding speed and accuracy by mastering correct keyboarding techniques. Students attain a minimum typing speed of 45 gross words per minute with a maximum of 5 errors on a 5-minute timed test. Topics include building speed and accuracy, formatting and producing business documents, language arts, and proofreading. Prerequisite: BUS 101 Offered quarterly
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5.00 Credits
Banner Title: Advanced Document Processing Students continue to develop keyboarding speed and accuracy by mastering complex document production. Students attain a minimum typing speed of 55 gross words per minute with a maximum of 5 errors on a 5-minute timed test. Topics include building speed and accuracy, integrated projects and applications, decision-making, language arts, and proofreading. Prerequisites: BUS 102, ENG 111 Offered quarterly
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3.00 Credits
Banner Title: Database Fundamentals This course emphasizes the use of database management software packages to access, manipulate, and create file data. Topics include data entry, data manipulation and updating, data access, database creation, and sort and print functions for file documentation. Prerequisites: Program admission, SCT 100 Offered Summer and Winter terms
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5.00 Credits
Banner Title: Office Procedures This business course emphasizes the essential skills required for the business office. Topics covered in the course include office protocol, time management, telecommunications and telephone techniques, office equipment, office mail, references, records managements, and travel and meeting arrangements. Prerequisite: Program admission Corequisite: BUS 101 Offered Summer and Winter terms
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3.00 Credits
Banner Title: Machine Transcription BUS 107 emphasizes transcribing mailable documents from recordings using word processor software. Topics include proper maintenance and usage of equipment and supplies, work area management, transcription techniques, proper formats, speed and accuracy, proofreading, grammar, spelling, and punctuation. Prerequisites: BUS 102, ENG 111, SCT 100 Offered Fall and Spring terms
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7.00 Credits
Banner Title: Word Processing This course emphasizes the intensive use of word processing software to create and revise business documents. Topics covered include equipment and supplies maintenance and usage, work area management, word processing software, and proofreading. Prerequisite: BUS 101 or SCT 100 Offered Summer and Winter terms
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