Course Description
Broad coverage of validation and control processes for the pharmaceutical, biologic, and medical device industries.
Athena Title
Process Control and Validation
Equivalent Courses
Not open to students with credit in PHAR 6120E
Non-Traditional Format
Three hours per week for fifteen weeks online study, including teaching, assignments, discussion, problem-based learning, and case-based learning. Weekend seminar(s) totaling eight contact hours (onsite or GSAMS multi-point video conference) utilizing case-based and problem-based learning methods.
Prerequisite
[(PHAR 6030 or PHAR 6030E) and BIOS(PHAR) 7100E] or permission of department
Grading System
A - F (Traditional)
Course Objectives
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
Topical Outline
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