This course will review the Medical Device Reporting Regulations as they relate to the manufacturer of medical devices and user facilities. Complaint Handling will be reviewed, and participants will be instructed on how to determine if a complaint meets the requirements for a Medical Device Report. Also discussed will be the forms required to be completed, the associated time frames, and what information is required to be included with the Medical Device Report.
- Identify the Manufacturer requirements and the User Facility requirements
- Determine what constitutes a Complaint and when a complaint must be reported under the Medical Device Regulation
- Complete the FDA Form 3500A
- Quality Personnel involved in the investigation of adverse event reports
- Regulatory Affairs Personnel responsible for submitting safety reports to FDA and other health authorities
- Medical Affairs Personnel responsible for safety-related decisions regarding product labeling, regulatory interactions, or customer communication
- Clinical Research Professionals involved with medical device trials and adverse event reporting
- From User Facilities, Risk Management Personnel involved in adverse event reporting
Douglas Albrecht, B.S.N., C.C.R.A.
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2 hours 1:00 – 3:00 p.m. Eastern
August 11, 2010
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471