FDA

Assignment 2 Individual Assignment Due: Oct 19, 2016 You have recently been hired to work at a medical device company. The medical device company has recently received a Complaint for forfeiture (seizure) from the FDA. The firm has hired you to help them ensure their manufacturing operations comply with the regulations (21 CFR 820). For your assignment, refer to the court document that identifies the FDA allegations of violations. http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM0564 90.pdf From this document identify a particular violation (Facts section parts A through K, include all subparts when selecting a section) and identify the regulatory requirements that the firm must meet to be in compliance. Provide a summary of the problem that is identified and describe how it failed to meet the requirements. For the cited violation, develop a corrective and preventive action (CAPA) that complies with 21 CFR 820.100 for the firm to implement. Identify all requirements for a CAPA and develop a plan that ensures that all elements of the CAPA are addressed including how the effectiveness of the CAPA will be verified or validated and describe how you would document these activities. Expected deliverable: A written report (approximately 5-10 pages). Additional resource: Final rule with preamble for the Quality System Regulation 61 FR 52602-52662 http://www.gpo.gov/fdsys/pkg/FR-1996-10-07/pdf/96-25720.pdf