BEC 475 & BEC 575 (Global Regulatory Affairs for Medical Products)
Fall 2014 - Final
1. This is NOT a group project you must do your own work.
2. Note that there may be more than one question in each problem. Answer them all.
3. Please use t
BEC 475/575 (Global Regulatory Affairs for Medical Products)
Fall 2014 - Midterm
1. Read all 10 problems before writing anything. Note that there may be more than one
question in each problem. Answer them all!
2. Initiate a MS Word file name
Job Title: Qualified Person
Experience in activities concerning qualitative and quantitative analysis of
medicinal products, such as direct and supervise operations to ensure quality
Experience in act
Executed Records, page 1-2
1. Blank spaces present in the table were
not crossed with N/A for not
applicable, and were not initialed
Compliance AuditBTEC Facility
A facility inspection was conducted inside the Golden Leaf Biomanufacturing Training
and Education Center Facility (BTEC) at North Carolina State University in Raleigh,
North Carolina. The BTEC facility is specif