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    Understanding FDA Regulations Governing GCP, GLP and GMP for Drugs, Biologics and Medical Devices

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    Website http://c2gowebinars.com/product/?topic=gcp-glp-gmp | Want to Edit it Edit Freely

    Category Biotechnology , Medical Device , Pharmaceutical

    Deadline: March 16, 2016 | Date: March 16, 2016

    Venue/Country: Online, U.S.A

    Updated: 2016-02-09 19:20:33 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    It is important for the FDA-regulated industry to better understand applicable FDA regulations governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP) for drugs, biologics and medical devices including in vitro diagnostics (IVDs).

    This webinar is intended to help the FDA-regulated industry get better familiar with the GLP, GCP and cGMP requirements from regulatory perspectives.

    Understanding and adequately implementing the regulatory requirements under GLP, GCP and cGMP regulations are critical to firm’s decision-making process, helping to save an enormous amount of resources.

    In this presentation, the speaker will discuss FDA regulations including key provisions and requirements governing GCP, GLP and GMP applicable to drugs, biologics and medical devices including IVDs.

    Areas To Be Covered in this Webinar:

    Laws and Regulations

    Definitions

    Good Laboratory Practice (GLP): Regulation and Important Requirements

    Good Clinical Practice (GCP): Regulation and Important Requirements

    Regulations for Current Good Manufacturing Practice (CGMP) for Food, Drugs, Biologics and Medical Devices

    FDA Guidance(s) and Standard(s)

    Best Practices When Implementing GLP, GCP and GMP: Dos and Don’ts

    Speaker’s PASS-IT Recommendations

    Who will benefit:

    Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.

    Compliance Officers

    Regulatory Affairs

    Clinical Affairs

    Quality Assurance

    Laboratory Personnel

    IT Professionals

    R&D

    Consultants

    Contractors/Subcontractors

    Other professionals interested in this topic

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    Copy of PowerPoint slides (PDF print only)

    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.