Term
| Inserting a gene into a hamster ovary so that the purified drug can be used to treat multiple sclerosis is an example of: |
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Definition
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Term
| producing an ear of corn that has mixed yellow and white kernels is an example of which type of biotechnology application |
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Definition
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Term
| Producing a shampoo that produces less lather for disposal into the water system is an example of which type of biotechnology apllication |
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Definition
| chemical/environmental application |
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Term
| Developing a quick test for AIDS is an example of which type of biotechnology application |
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Definition
| Medical/health care application |
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Term
| When a dog is examined for the effects of the medication on his hair, this is an example of which step in drug research and development? |
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Definition
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Term
| Running computer models to determine which direction the testing process should take for the new drug is an example of which step in drug research and development? |
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Definition
| research and development in the lab |
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Term
| Mary has decided to participate in a study for how well a drug company's newest GI drug works. This is an example of which step in drug research and development? |
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Definition
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Term
| The average length of time it takes for a drug to make it to market from the initial preclinical testing is: |
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Definition
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Term
| What is the first step in drug development |
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Definition
| research and development in the lab |
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Term
| what is the middle step in drug development |
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Definition
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Term
| What is the last step in drug development? |
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Definition
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Term
| What is the purpose of pre-clincal testing |
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Definition
| to establish safe boundaries for when human studies begin |
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Term
| The phase of human clinical studies that involves the smallest number of people |
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Definition
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Term
| The human clinical trial phase that involves the largest number of people |
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Definition
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Term
| The human clinical trial phase that increases the initial number of human participants |
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Definition
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Term
| The New Drug Appliction Review is submitted to the FDA at: |
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Definition
| once all or most of the proposed studies are completed |
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Term
| Phase IV studies of a drug are: |
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Definition
| performed to learn more about side effects and long-term risks and benefits |
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Term
| Separating out the "soup" in the production of pharmaceuticals is which step of the production process? |
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Definition
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Term
| Containers are labeled and packaged during which step of the production process? |
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Definition
| final dosage form preparation |
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Term
| Bioreactors may be used during which step of the production process? |
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Definition
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Term
| Mixing the active ingredient with the filler is during which step of the production process |
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Definition
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Term
| This step proves that a manufacturing process will conistently produce the product to predefined specifications |
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Definition
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Term
| This step requires companies to prepare and follow SOPs by the FDA |
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Definition
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Term
| This step is where employees sample and test the raw materials and the product during many stages of the manufacturing process |
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Definition
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Term
| When two coworkers analyze the steps they could improve on when producing a quality product, this reflects what: |
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Definition
| Understand customer needs |
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Term
| Jennie fills out a log with the materials used to manufacture the product. What does this reflect? |
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Definition
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Term
| Nancy refers to the procedure book to be sure she is following the exact procedures. What does this reflect? |
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Definition
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Term
| When changes are made in the manufacturing process, the manager writes it down so that it is a traceable, written record. This reflects what? |
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Definition
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Term
| When Marty attends an inservice on how to operate a new piece of equipment she is demonstrating which of the employee success skills? |
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Definition
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Term
| Heidi puts on a protective suit when handling certain chemicals. She is demonstrating which employee success skill |
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Definition
| maintain a safe and orderly work environment |
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Term
| Terry reads the standard operating procedures manual to be assured that she completes the procedure correctly. She is demonstrating which employee success skill? |
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Definition
| follow procedures exactly |
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Term
| Tutti is able to work her station as well as sort new orders at the same time. She is demonstration which employee success skill? |
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Definition
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Term
| When Tammy emails all of the management about changes in the manufacturing process, she is demonstrating which employee success skill? |
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Definition
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Term
| When Cody updates the notebooks to show corrected standard operating procedures, he is using which employee success skill? |
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Definition
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Term
| When Wanda figures out how to increase the speed of the production, she is using which of the following employee success skills? |
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Definition
| Solve problems, troubleshoot, and improve the process |
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Term
| Val shows how to set up a "Go To" meing on the computer. She is using which employee success skills |
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Definition
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Term
| Manufacturing Prep Process Technician |
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Definition
| washing, drying and sterilizing glassware |
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Term
| Formulation/Fill technician |
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Definition
| Prepares the finished product from the purified active biopharmaceutical ingredients |
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Term
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Definition
| Labels, inspects and packages the finished product |
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Term
| Process Engineer in Manufacturing |
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Definition
| Designs, develops and operates the current manufacturing process |
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Term
| Process Engineer in Process Development |
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Definition
| Does design, scale-up and validation of new processes |
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Term
| Quality Control Assistant |
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Definition
| Analyzes raw materials, in-process samples and finished formulations by SOPs |
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Term
| Quality Control Associate |
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Definition
| Coordinates activities to document good manufacturing practices |
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Term
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Definition
| Develops, revises and maintains standards for converting raw materials into products |
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Term
| Process Quality Inspector |
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Definition
| Inspects, tests, and samples procedures related to the manufacturing process |
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Term
| Quality Assurance Associate |
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Definition
| Writes and edits SOPs, lab procedures manuals and other documents |
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Term
| Quality Assurance Auditor |
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Definition
| Performs audits of production and quality control |
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Term
| Instrumentation/ calibration technician |
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Definition
| Calibrates, tests, repairs and maintains a variety of instrumentations |
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Term
| Manufacturing support technician |
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Definition
| Maintains manufacturing equipment and solves production problems |
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Term
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Definition
| Performs routine environmental testing and carries out waste treatment operations |
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Term
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Definition
| Involves maintenance and repair of refrigeration, air conditioning, steam boilers, etc. |
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Term
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Definition
| Designs and installs instruments to monitor and control manufacturing processes |
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Term
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Definition
| Designs waste storage, treatment and recycling facilities |
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Term
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Definition
| Performs lab experiments and test according to good lab practices |
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Term
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Definition
| Seeks new and more efficient ways to use and produce existing products |
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Term
| Customer Support Specialist |
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Definition
| Contact for customers with technical questions |
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Term
| Clinical Trials Associate |
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Definition
| Assists and monitors the management of clinical trials |
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Term
| Regulatory Affairs Specialist |
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Definition
| Coordinates and prepares a variety of documents to submit to the FDA |
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