Master Drug and Medical Device Reporting (MDRs)

MessageThis Webinar is over
Date May 20, 2014
Time 10:00am
Cost $195.00
Online
Overview:
Manufacturers of APIs, Final Drug Products and Medical Devices are required to report to the FDA when they learn that any of their products may have caused or contributed to a death or serious injury or if there is an anticipated patient risk. Manufacturers must report to the FDA when they become aware that their product may or has malfunctioned and would be likely to cause or contribute to a death or serious patient risk. The FDA's regulations contain mandatory requirements for manufacturers, importers, and device user facilities to report certain product-related adverse events and product problems to the FDA.

Importers: Importers are required to report to the FDA and the manufacturer when they learn that any of their components or raw materials that are used to produce or assemble the final product may have been identified as having patient risk (e.g. formulation or sterility)which may have been identified as having potential patient risk or has already caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur. 

Why Should You Attend: 
The FDA expects health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a drug and/or medical device, as well as use errors, product quality issues, and quality failures. The overall intent of this program, just like FAA for passenger safety is to provide critical information that helps improve patient safety.

Areas Covered in the Session:
  • Document approval and distribution
  • Document changes.
  • Evaluation of suppliers, contractors, and consultants
  • Purchasing data
  • Identification - 820.60
  • Traceability - 820.65
  • Control of nonconforming product
  • CAPA
  • QSR Requirement's.
Who Will Benefit:
  • Quality Assurance (QA)
  • Operations Management
  • Regulatory Management
  • Internal Auditors
  • Quality System Managers
  • Complaint system personnel
  • Regulatory Associates

 


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