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Course Criteria
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0.00 Credits
This course will focus on the regulation of product produces in the life science sector including strategic planning, compliance, validation and documentation of production. Students will gain an understanding of the role of regulatory affairs in the overall business scheme. Differences between the regulatory requirements of the U.S. market compared to the European and Asian markets will be examined. Contact hours: Class - 5, Lab - 0. Credit hours: 5. (T)
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0.00 Credits
This course is an introduction to the principles of current good manufacturing practice (cGMP) as described by the Food and Drug Administration (FDA) in the Quality Systems Regulations. Application of these principles to the life sciences, particularly biomanufacturing will be emphasized. Contact hours: Class - 3, Lab -0, Credit hours: 3. (T)
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3.00 Credits
(Prerequisite: Diploma level proficiency in English and reading) A laboratory course that will familiarize students with some basic procedures and techniques common to laboratories involved with work that is covered by Quality Systems Regulation (QSR) and current Good Manufacturing Practices (cGMP). The principles of Good Laboratory Practices (GLP) and effective documentation procedures will be stressed. Contact hours: Class - 1, Lab - 3, Credit hours: 2. (T)
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3.00 Credits
This course provides an overview of documentation and validation concepts used within a biomanufacturing facility. Emphasis will be placed on source documentation, writing and executing Standard Operating Procedures (SOPs), process and equipment validation, as well as validation of bulk starting materials. Contact hours: Class - 1, Lab - 3. Credit hours: 2. (T)
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3.00 Credits
(Prerequisite: BUS 101) Continues the development of keyboarding speed and accuracy with further mastery of correct keyboarding techniques. Students attain a minimum typing speed of 40 words per minute with a maximum of 5 errors on a 5-minute timed keyboarding test. Topics include building speed and accuracy, formatting and producing business documents, language arts, and proofreading. Laboratory practice parallels class instruction. Contact hours: Class - 1, Lab - 9. Credit hours: 5. (E)
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3.00 Credits
(Prerequisites: BUS 102; BUS 108; ENG 111or ENG 191) Continues the development of keyboarding speed and accuracy with mastery of complex document production. Students attain a minimum typing speed of 50 words per minute with a maximum of 5 errors on a 5- minute timed keyboarding test. Topics include building speed and accuracy, integrated projects/applications, decision making, language arts, and proofreading. Laboratory practice parallels class instruction. Contact hours: Class - 1, Lab - 9. Credit hours: 5. (Sp, F)
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4.00 Credits
Emphasizes use of database management software to access, manipulate, and create file data. Topics include: data entry, data access, data manipulation, database creation, and file documentation. Contact hours: Class - 1, Lab - 4. Credit hours: 3. (Su, W)
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0.00 Credits
Emphasizes essential skills required for the business office. Topics include: office protocol, time management, telecommunications and telephone techniques, office equipment, office mail, references, records management, and travel and meeting arrangements. Contact hours: Class - 5, Lab - 0. Credit hours: 5. (E)
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4.00 Credits
Emphasizes transcribing mailable documents from dictation using word processing software. Topics include equipment and supplies maintenance and usage, work area management, transcription techniques, productivity and accuracy, proofreading, and language arts skills. Contact hours: Class - 1, Lab - 4. Credit hours: 3. (F, Sp)
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6.00 Credits
Emphasizes an intensive use of word processing software to create and revise business documents. Topics include equipment and supplies maintenance and usage, work area management, word processing software, and proofreading. Contact hours: Class - 4, Lab - 6. Credit hours: 7. (E)
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