Submit your topic typed into the submission box . The contents of your typed submission should include: Organization or Company, Date of Regulatory Infraction(s), Type of issue and Why you chose it. Be sure to demonstrate how this topic meets the term paper topic criteria.
Choose a case study based on the following criteria:
- Considered a best practice case study. A major quality or compliance incident was identified and successfully resolved.
- Note: incidents related to human resources, ethics violations or finances are not considered quality or compliance incidents.
- From an industry in healthcare
- Issue can be linked to a regulation that has been violated, or a major quality system gap or breach.
- Discussed in at least three peer-reviewed journals/references.
- Piques your interest.
- Within the past five years (unless approved by Professor).
- Follow APA format for all written work.
We need to select A major quality or compliance incident that occurred and was identified and successfully resolved.
Anything related to healthcare
We need to select a major healthcare organization or anything that was a compliance issue
Select form any of two
Take a look at these topics and let me know (by posting as your submission for the topic into the homework assignment) if either are of interest to you:
Valsartan contamination with NDMA
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhejiang-huahai-pharmaceutical-566685-11292018
Meridian Medical Technologies, Epipen
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/meridian-medical-technologies-inc-pfizer-company-525881-09052017
