Internet Issues for FDA Regulated Industry – A Review of Issues Involving Social MediaIntroduction to Medical Device Regulatory Affairs
The medical device industry is strictly regulated in the U.S. by the FDA.
Why should you attend :
An introductory look at US medical device requirements throughout the lifecycle of the medical device. This course would be interesting for anyone in or out of the Medical Device Industry interested in learning more about Regulatory Affairs, and its role in product development, FDA submission, manufacturing, and post-market requirements.
Areas Covered in the Session:
"FDA Origin and Functions
What it means to be compliant, and what happens if you are not compliant.
Regulatory Affairs role in device approvals, and post-market activities.
Overview of the 21CFR800-series of regulations
FDA Post-Market tools and requirements"
Who will benefit: (Titles)
Medical Device companies, or individuals interested in regulatory affairs in the medical device industry.
Q/A Session with the Expert to ask your question
A copy of the PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance
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