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    Electronic Records & Electronic Signatures, 21 CFR Part 11 , Basic Concept

    View: 209

    Website https://compliance2go.com/product/?pid=CP2014-364 | Want to Edit it Edit Freely

    Category Biotechnology , Medical Device , Pharmaceutical

    Deadline: September 24, 2014 | Date: September 24, 2014

    Venue/Country: Houston, U.S.A

    Updated: 2014-08-27 18:02:17 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    With the emerging utilization of computerized technologies in the late 1980s and early 1990s, the pharmaceutical industry asked the FDA for guidance regarding compliance of the resulting electronic records. After several years of development and industry comments, 21 CFR Part 11, the Electronic Records & Electronic Signatures Rule became law in 1997. Interestingly, as time passed other international regulatory agencies adopted similar e-records/e-signature regulations. Today, more than 15 years after introduction, compliance with the requirements of Part 11 (as the regulation is now commonly referred to) continues to challenge the industry. As with any regulation, understanding the basic requirements is key to achieving compliance. This presentation will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements, electronic records requirements, and electronic signatures requirements.

    Why should you attend :

    Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in efficiency…both efficiency in project management, and avoidance of non-compliance penalties.

    Areas Covered in the Session:

    History and Overview

    Subpart A: General Provisions

    Subpart B: Electronic Records

    Subpart C: Electronic Signatures

    Scope & Application Guidance

    Questions and Answers

    Who will benefit:

    Project/Strategic Management

    Quality Assurance staff

    IT staff

    Operations staff

    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.
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