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Recorded Webinar
US FDA Regulations: Food, Drugs, Biologics and Medical Devices
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
United States Food and Drug Administration (“FDA”) is the federal agency responsible for ensuring that foods are safe; drugs for human and animals, biologics and medical devices are safe and effective; electronic products that emit radiation as well as cosmetics are safe. As rules and regulations help FDA ensure that regulated products are safe and effective, it is imperative we understand the applicable regulations (Title 21 of the Code of Federal Regulations for Food and Drugs “Title 21: Food and Drugs”) and also be able to accurately interpret the said regulations to better meet the regulatory requirements necessary for FDA approval or clearance to market drugs, biologics, medical devices and food additives. In this presentation, the Title 21: Food and Drugs, the codification of the general and permanent rules and regulations (sometimes called as administrative law) for Food and Drugs, will be discussed.
The presentation will cover the following areas:
- Title 21: Food and Drugs, the codification of the general and permanent rules and regulations (sometimes called as administrative law) for Food and Drugs
Who should attend
This overview webcast is intended for individuals whose functions have direct or indirect involvement with FDA inspections. These functions include among others:
- Regulatory Affairs
- Quality Assurance Staff
- Scientists
- Quality Assurance Staff
- Documentation Management
- All staffs who are assigned GLP responsibilities
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