How to ensure supply chain integrity in Medical Devices. Identifying weak links and mitigating risks.
American Medical Association (AMA) Style
Capstone Paper for Regulatory Affairs. Research Paper with References. Masters Level.
Main topic: Medical Devices Supply Chain Integrity (FDA Regulations)
This is NOT an IT related paper and should have nothing to do with IT.
Add subtopics. (The problem I have with this instructor is that she says my writing has no “premise” I have a hard time creating an outline.”
Include data and facts where applicable.
● How is this topic relevant in the current regulatory landscape?
● Why does this topic matter to people not in the regulatory field?
Directions from Instructor:
(use at least two levels, i.e., sub-topics within your broader topic area). DO NOT USE generic headings like findings and analysis; instead, use descriptive headings that help the reader see what is coming and how your discussion is evolving. For example, for the topic Regulatory Barriers for Therapeutic Marijuana Pharmaceutical Development, descriptive subheads after Introduction (generic) could be Current Marijuana Context, Agency Guidance and Enforcement, Current Pharmaceutical Products Challenges, How to Encourage Development, and Conclusions (generic).
Focus on Logistics, Medical Device transportation. Here is article
https://www.logisticsmgmt.com/article/using_technology_to_de_risk_supply_chains
Include information about DSCSA Drug Supply Chain Security Act (DSCSA)
Here is a link: https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
