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 course provides an introduction to risk management as outlined in ISO 14971 ISO 13485, and ICH Q8, Q9, and Q10, which are recognized standards by most Western Medicinal Products Safety Agencies responsible for regulating medicinal products. Students will learn by applying knowledge gained from standards, guidance documents, and FDA regulations, as well as www.FDA.gov website search skills in working through 3 FDA case studies that look at regulatory pathways to US marketplace, safety assurance case for a medical device, and bringing an innovative medical device to US marketplace via premarket approval.

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

1. Apply risk management techniques throughout the product life cycle.
2. Analyze risk management techniques throughout the product life cycle.
3. Apply FDA GMP regulations to include title 21 Parts 58, 210,211, 600, 601, 820.
4. Evaluate FDA GMP regulations to include title 21 Parts 58, 210,211, 600, 601, 820.
5. Apply ISO 14971 and ICH Q8, Q9, and Q10 in the context of complying with FDA cGMP regulations.
6. Evaluate ISO 14971 and ICH Q8, Q9, and Q10 in the context of complying with FDA cGMP regulations.
7. Apply and evaluate risk analysis and risk controls using a variety of risk analysis approaches.
8. Recognize and apply Risk Evaluation and Mitigation Strategies (REMS), Failure Mode Effect Analysis (FMEA), Failure Mode, Effect and Criticality Analysis (FMECA), Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), Hazard Operability Analysis (HAZOP), and Change Management (CM).
9. Recognize and identify methods to enable safer prescribing behavior to better mitigate risk and Human factor analysis.
10. Identify and summarize information from authoritative websites each week in Share the Knowledge discussion postings and analyze other students’ posts.
11. Search 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.

• Risk Management Part 1 ISO 14971
• Risk Management Part 2 ISO 14971, ISO 13485, IHC Q9, 21 CFR 820
• ANSI Standards and FDA Searchable Databases
• ICH Q9, REMS, Risk Analysis Methods
• Biologics FDA Case Study 1: “Regulatory Pathways for Choosing Medical Devices: Choosing the Right One”
• Case Study 2: “Freedom from Unacceptable Risk: Making a Case for Safety Assurance and Risk Management”
• Case Study 3: ”Bringing an Innovative Device to Market: Premarket Approval (PMA) of Medical Devices”
• Case Study 4: ”API Coating Process of Saxagliptin” ICH Q9 and Q10