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You are developing a Standard Operating Procedure (SOP) for the handling of product complaints relating to marketed medicines.List the key aspects that should be addressed in the procedure section of the SOP according to PIC/S GMP requirements relating to the receipt of the complaint and documentation thereof.

Students cannot pass this course without accessing the course information in Canvas and reading the textbook. 

On the syllabus under COMPUTER & INTERNET REQUIREMENTS, it says that you CAN complete this class on a phone or tablet.

A patent gives an inventor the exclusive right to which of the following?

The CEO and CFO of Phoenix Capital, an asset management company, for years underreported the company’s income to avoid paying high taxes. They did this by claiming too many deductions on their tax returns and by funneling some of their money to offshore accounts. Could the managers of Phoenix be held liable under the business judgement rule?

Frank and Eduardo were the majority shareholders and sole officers and directors of Uno-vision, a Spanish television station incorporated in Delaware as an LLC. They never held meetings to discuss the business affairs of Uno-vision, LLC or to assess its financial condition. Over time, several employees stole money from the company, but Frank and Eduardo never investigated the situation or terminated those employees. Eventually, the company went into bankruptcy, and several business clients of Uno-vision, LLC sued the corporation—and Frank and Eduardo individually—for breach of contract. Can a court of law hold Frank and Eduardo personally liable for the failure of the business?

Elena is approved for FMLA leave from her job at Apex Health to care for her mother after surgery. While on leave, Elena takes a vacation to Mexico, despite company policy requiring employees on leave to remain available for contact and not travel internationally without prior approval. HR discovers the trip and terminates her for violating the policy. Elena sues, claiming she was fired for using FMLA leave. Who is likely to prevail?

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?

A corporation hired a bidding agent to represent the corporation at an auction of land. The written agreement authorized the agent to bid on a property of interest for up to $250,000. At the auction, the land in which the corporation was interested was subject to fiercely competitive bidding. The agent won the auction at $500,000, instead of $250,000. The corporation refused to pay more than $250,000. If the auctioning party sues the corporation and the bidding agent to recover the money owed, against whom will they win?

Akeno, an employee of VTax, is hired as a sales representative. In his role, he is given the authority to negotiate and finalize sales contracts on behalf of VTax. One day, Akeno signs a contract with a supplier that offers him a personal commission, which he does not disclose to VTax. Akeno has most likely violated the duty of [BLANK-1]. Fill-in-the-Blank Instructions: Your answer must be one- or two-word legal terminology only. Do not write full sentences or explanations. Longer responses are difficult for the software to grade and will not receive credit.