A pharmaceutical manufacturer outsources microbiological tes…
A pharmaceutical manufacturer outsources microbiological testing of finished products to an external laboratory. No technical agreement is available describing responsibilities for sample handling, testing, investigations, or data reporting. According to GMP principles, what is the primary concern?
Read DetailsDuring supplier qualification activities, a pharmaceutical m…
During supplier qualification activities, a pharmaceutical manufacturer reviews several certificates of analysis received from an API supplier over a six-month period. The reported analytical results are identical across multiple batches to the same number of decimal places. According to PIC/S GMP data integrity principles, what is the most appropriate concern?
Read DetailsA pharmaceutical company outsources stability testing to an…
A pharmaceutical company outsources stability testing to an external laboratory. The technical agreement specifies testing responsibilities but does not define responsibilities for investigation of out-of-specification (OOS) results. Why is this considered inadequate?
Read DetailsA real estate development company is headquartered in State…
A real estate development company is headquartered in State A, manages properties and conducts business primarily in State B, but is incorporated in State C. The company files annual reports and registers to do business in both State A and State B as required by those states’ laws. Under corporate law, which state’s laws govern the company’s internal affairs, including its bylaws, articles of incorporation, and board governance?
Read DetailsDuring chemotherapy for bone cancer, Pete, a 45-year old del…
During chemotherapy for bone cancer, Pete, a 45-year old delivery man, is exhausted, nauseated and weak. He asked permission of his employer, Vulcan, to come in later, work a shorter day and limit his lifting to 10 pounds for at least 4 months. Vulcan is a small company with only 3 delivery workers and 2 office workers. Vulcan told Pete that it could not accommodate him and that he was being laid off. Has Vulcan violated any laws?
Read DetailsKush is a lawyer for W&K, LLP- a law firm that represents th…
Kush is a lawyer for W&K, LLP- a law firm that represents the public company Asklaw. He was drafting legal documents for the merger between Legal Zoom and Asklaw, two companies that provide on-line legal research for lawyers. Kush told his girlfriend, Leah, about the deal and how profitable it will be for Asklaw. One day, Leah was having lunch with Mina–a second year law student who interned with W&K and worked directly under Kush. Out of the blue, Leah asks Mina if she has ever used Asklaw to conduct research. When Mina mentioned that “she loves Asklaw” , Leah responded, “well, I hate to break it to you but it is about to get bought by another company.” The next day, Mina purchased 1000 shares of Asklaw for a mere $10 a share. After 4 months of owning the stock, when the merger between Legal Zoom and Asklaw was publicly announced, the value of Mina’s shares tripled and she sold them for a profit. Who could the SEC prosecute for insider trading in this scenario?
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