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    SOP and FDA Compliance

    View: 119

    Website https://compliance2go.com/product/?pid=CP2014-329 | Want to Edit it Edit Freely

    Category Medical Device

    Deadline: July 24, 2014 | Date: July 24, 2014

    Venue/Country: online, U.S.A

    Updated: 2014-07-15 18:14:26 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. Worse, this often leads to many regulatory errors that first come to light during and FDA audit.This webinar will show you how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

    Areas Covered in the Session:

    SOPs and their relation to the regulations

    SOPs as part of the company's regulatory infrastructure

    SOP on SOPs and how to ensure conciseness, consistency and ease of use.

    Risk Based approach on SOP Best Practices for creation and maintenance.

    Training on SOPs

    Tools for SOP tracking and when is validation required

    What the FDA looks for in SOPs during an inspection

    Who will benefit:

    Anyone that creates / maintains SOPs

    VP

    Director, Manager of any dept that writes SOPs or performs training

    QA / QC

    Regulatory Affairs Titles

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    90 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.