Submit a paper on your topic. Include: Organization or company, date of regulatory infraction(s), type of issue and why you chose it.

Valsartan contamination

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.

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.

Select a major quality or compliance incident that occurred and was identified and successfully resolved.

Anything related to healthcare

Select a major healthcare organization or anything that was a compliance issue

Select form any of two

Take a look at these topics:

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