Quality Inspection in Pharmaceutica Industry Discussion
Question Description
I’m working on a english discussion question and need an explanation and answer to help me learn.
1) Inspection Preparation discussion
You are the director of the compliance team, and you have been asked to prepare your organization for an upcoming FDA inspection in six months. You work for a pharmaceutical company with over 10,000 employees and eight major product lines. Assume the company has a solid quality system in place, and most employees are trained appropriately in quality and their roles. However, like any large company, there are some quality issues and plenty of CAPAs.
How would you prepare for the audit? Please include your reasons for the steps you would take.
2) Quality System Inspection Techniques (QSIT) Discussion
What are the steps an FDA inspector would follow in conducting an audit at a health care manufacturer (pharma or medical device)? Assume they are following the QSITs laid out by their management team.
What are the benefits of following QSIT and why do you think the FDA uses it?
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