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Course 3636
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What is the first step a company should take if interested in using artificial intelligence?
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If a company documents its work and data on paper, instead of in computer systems, this is technically compliant with the regulations, but does not meet regulator expectations for a modern operation. FDA would be concerned that a paper-based company, with thousands of records and millions of data points, would not be able to:
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An Investigational New Drug (IND) application allows the company to do which of the following (Select one):
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In the manufacturing videos you viewed during class, the manufacturing areas were pristine in order to protect patients by preventing:
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In order for a Class II Medical Device to be cleared for market access in the United States, a company (amongst other requirements) must always:
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The table included with this question shows composite assay data for 2 sample preparations. The average of the 2 results (90.3%) is within the specification range of 90.0 - 110.0%. In the Barr Court Case, we learned that releasing this product is not acceptable. Which of the following is true of averaged data? (Select one):
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While on inspection at a pharmaceutical plant site in the United States, FDA finds critical failures that impact product quality and safety. The agency finds many violations related to the Quality System, such as having no evidence of employee training, no batch records for manufactured product, missing laboratory data, and no failure investigation reports for manufacturing failures. What would be the likely outcome of this inspection? (Select one)
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While on inspection, FDA reviews multiple investigation reports related to product dryer failures. These failures occur sporadically, but after investigation, your site has claimed that there is no risk to the product quality or safety. As a result, your company is still using the equipment to manufacture and release product to the market, even though you have not found the root cause for the failures to fix the problem. What is the most likely FDA response to this situation? (Select all that apply)
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Match the description to the corresponding type of qualification:
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If you are an FDA official conducting an inspection of a company, how would you assess how strong that company's culture of quality is? In other words, provide 1 example of an activity you would expect to see, and provide 1 example of an activity you would expect not to see. Explain how those activities would give you a sense of the company's culture of quality.
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