Question: Section G-Writer’s Bloc (3 Points Each, 15 Total) Answer ALL Of The Following Questions In Your Own Words. Target Length Is Approximately 2- 3 Paragraphs Each, But They Can Be As Long As You Need Them To Be. Note: What” And “how” Are Different Questions, Dont Lose Points Failing To Answer Both. 1) What Was The Industrial Bio-Test Scandal And What/how …

Section G-Writer’s Bloc (3 points each, 15 total) Answer ALL of the following questions in your own words. Target length is approximately 2- 3 paragraphs each, but they can be as long as you need them to be. Note: What” and “how” are different questions, dont lose points failing to answer both. 1) What was the Industrial Bio-Test scandal and what/how did it contribute to current pharmaceutical industry regulations (be specific)? 2) Compare and contrast ICH Q7 and 21 CFR Part 211. Who made each? What products or materials does each cover the same and differently from each other? Describe the kind of guidelines each provides. Cite specific topical examples to show at least 4 ways they treat the subject similarly, and 4 ways they treat the subject differently. 3) Discuss at least five different activities that would constitute Good Documentation Practices, as described in class. You can write these as bullet points rather than paragraphs, if you wish. 4) What was the Tuskegee Syphilis Study and what/how did it contribute to current pharmaceutical industry regulations (be specific)? 5) Compare and contrast the concepts of Commissioning, Qualification, Verification, and Validation. Provide a definition of each term in your own words, and demonstrate the difference between each concept using for your examples an automobile that you wish to purchase.