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    FDA Regulations for Food, Drugs, Biologics, Cosmetics, and Medical Devices Including IVDs

    View: 216

    Website https://compliance2go.com/product/?pid=CP2014-353 | Want to Edit it Edit Freely

    Category Biotechnology , Medical Device , Pharmaceutical

    Deadline: September 09, 2014 | Date: September 09, 2014

    Venue/Country: Houston, U.S.A

    Updated: 2014-08-21 18:30:27 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    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

    Definitions

    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

    Quality

    Regulatory Affairs

    CEOs

    VPs

    Attorneys

    Clinical Affairs

    R&D

    Consultants

    Contractors/Subcontractors

    Anyone Interested in the Regulations Governing Food, Drugs, Cosmetics, and Medical Devices And IVDs

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    60 Minutes Live Presentation

    Certificate of Attendance


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.