For the midterm essay exam, you will be required to analyze this FDA warning letter. You should include all of the following elements in your essay:
1. Case Analysis
Provide a brief analysis/summary
Identify the problem(s)/issue(s)
3. Solution(s) and Recommendation(s)
Provide a solution(s) for the identified problem(s)/issue(s). What would you recommend as an RA professional?
Provide a conclusion as follows:
· As an RA professional what lesson (s) am I learning from this incident?
· How will this information help me in the future?
In addition, your essay should be prepared, formatted and submitted as detailed below:
Format: Essay–APA style
Length: 4–6 pages
Description: Double-spaced, 12-point Times New Roman font
Expectations: Prepare your analysis in Word and submit it to the Week 6 assignment folder in the Assignments area
This is a graduate class called the practical application of biotech regulatory affairs, this class is about FDA regulations when it comes to drug products.