For The Midterm Essay Exam You Will Be Required To Analyze This Fda Warning Lett

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

2. Problem(s)

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?

4. Conclusion

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.

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