BIOT 218 - Product Life Cycle & Capstone

or Program Advisor Approval.
PREREQUISITES/COREQUISITE: BIOT 216 - Drug & Device Risk Management

or Program Advisor Approval.

PROGRAM: Biotechnology
CREDIT HOURS MIN: 3
LECTURE HOURS MIN: 3
DATE OF LAST REVISION: Fall 2022

This is the last of the four Regulatory Affairs online courses that have been designed to teach the skills and knowledge required by the medicinal product and biotechnology industries. The first four weeks of this course provide a basic introduction to medicinal product lifecycle, and the last 12 weeks are focused on completing one of three possible capstone projects (student’s choice with instructor guidance) that incorporate skills and knowledge acquired from the three previous courses as well as the first four weeks of this course.

MAJOR COURSE LEARNING OBJECTIVES: Upon successful completion of this course, the student will be expected to:

1. Search, locate, and apply regulatory information and guidance as it pertains to Investigative New Drug (IND), Biologic Licensing Application (BLA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), FDA databases, and standards.
2. Distinguish and compare how product life cycles differ amongst drugs, biologics, medical devices, and combination products to include surveillance monitoring post commercialization.
3. Comprehend, demonstrate, and analyze information from authoritative websites each week in Share the Knowledge discussion postings and replies.
4. Search, locate, and apply regulatory information and guidance as it pertains to Investigative Device Exemption (IDE), Pre-Market Approval (PMA), and FDA CDRH databases: e.g., FOIA reading room, MAUDE, 510k, recalls, standards, classification, and PMA.
5. Understand and apply medical device design guidance from the FDA.
6. Apply ISO 14971, ICH Q9, and FDA cGMP regulations in medicinal product formation.
7. Research, interpret, and apply information located in MAUDE, FAERS, Recalls, CDRH FOIA, Device Classification, REMS, title 21 CFRs, Warning letters, TPLC, PMA, 510(k), and many more databases found within FDA.gov website
8. Meet with the instructor to discuss your capstone project and its progress from three possible options: 510k Submission, IVC Filter, or Pre-Submission Meeting with FDA.
9. Demonstrate the ability to search appropriate regulations, guidance documents, and standards databases to complete the capstone project.
10. Demonstrate the ability to create a regulatory packet as directed by one of the three capstone projects.
11. Demonstrate the ability to write in a concise, persuasive, and logical manner in order to convey a compelling narrative to the FDA.

• Product Life Cycle Management
• Product Life Cycle Drugs and Biologics
• Product Life Cycle Medical Devices
• Risk Management 1 - ISO 14971
• Choose Capstone Project from three possible projects: 510k Submission, IVC Filter, or Pre-Submission Meeting with FDA.