Apply established principles of process control and validation 

Describe process control and validation requirements for 
product designs 	

Identify the elements of successful validation 

Describe the critical parameters of a chosen validation process 

Identify requirements pertinent to validation and routine 
process control 

Describe the critical factors in making product release 
decisions 

Identify resources for complying with FDA requirements

Write validation protocols 

Perform validation studies for a variety of pharmaceutical, 
biotechnology and device applications

A survey of controls for processes in pharmaceutical, 
biotechnology, biodevice including, production economics, plant 
layouts, economic considerations, material management.  
Provides overview for identifying, writing and performing 
validation processes for manufacturing specific dosage forms, 
including FDA rationale, and documentation requirements

All academic work must meet the standards contained in A Culture
of Honesty. Each student is responsible to inform themselves
about those standards before performing any academic work. A
Culture of Honesty is the University of Georgia's policy and
procedures for handling cases of suspected dishonesty and can be
found online at www.uga.edu/ovpi. UGA Student Honor Code states
"I will be academically honest in all of my academic work and
will not tolerate academic dishonesty of others."