2014-08-08 13:55:08 -
Have you ever wondered what regulations are applicable for food, drugs, biologics, cosmetics, medical devices including IVDs in the US?
This presentation is intended to help you get familiar with the US regulations governing food, drugs, cosmetics, and medical devices and cosmetics including in vitro diagnostic medical devices (IVDs).
This presentation will present key regulatory requirements as set out in the US regulations for food, drugs, medical devices including IVDs and cosmetics. To bring medical products to the US markets, it is imperative that the firms accurately understand and interpret the relevant and applicable regulatory requirements for medical products to obtain United States (US) Food and Drug Administration (FDA)’s clearance or approval. The Federal Food, Drug, and Cosmetic Act (FD&C Act
or the Act) and other statutes, if applicable, provide statutory requirements for marketing clearance or approval for food, drugs, cosmetics, and medical devices including IVDs from FDA. In this presentation, an overview of FDA regulations applicable for food, drugs, cosmetics and medical devices including IVDs will be presented.
This presentation is a must for anyone (domestic and foreign) including those who are involved in either directly or indirectly handling medical products (food, drugs, biologics, cosmetics, medical devices and IVDs).
Areas To Be Covered in this Seminar :
FDA Laws and Regulations
Label and Labeling
Regulatory Requirements Subject to Manufacturers for Food, Drugs, Biologics, Cosmetics, and Medical Devices including IVDs
Good Manufacturing Practices for Food, Drugs, Biologics, and Devices including IVDs
Regulatory Requirements for Investigational New Drug Application (IND)
Regulatory Requirements for Investigational Device Exemption (IDE)
Common Non-compliance Issues and Consequences
FDA Enforcement Actions: Recent Cases
Best Practices to Achieve Compliance and to Stay Compliant
PASS-IT Suggestions and Recommendations
Who will benefit:
Medical Device Quality and Compliance Professionals
Pharmaceutical Compliance Professionals
Anyone Interested in the Regulations Governing Food, Drugs, Cosmetics, and Medical Devices And IVDs