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    FDA’s Part 11 ? Enforcement Trends and Affordable Steps to Take Today

    View: 210

    Website https://compliance2go.com/product/?pid=CP2014-371 | Want to Edit it Edit Freely

    Category Biotechnology , Medical Device , Pharmaceutical

    Deadline: December 26, 2014 | Date: December 26, 2014

    Venue/Country: Houston, U.S.A

    Updated: 2014-11-13 18:31:40 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    Learn how FDA is enforcing 21 CFR 11 today, why you can use this to your advantage, and how to put in place a cost-effective, risk-based Part 11 compliance program today. Learn the SOPs and policies to have, how to incorporate risk assessments, and how to tackle suppliers such as CROs, CMOs and distributors who maintain regulated records on your behalf.

    Why you should attend

    Since 2010, FDA has embarked on a special enforcement and training of its investigators on 21 CFR 11.

    Increasingly, Part 11 is an easy way for an investigator to cite a firm for failure to comply with the QSRs, GMPs, GLPs or GCPs. So if you don’t want to receive a Warning Letter from FDA citing you for data quality issues ? or you don’t want your submission to FDA to be put on hold due to data integrity questions ? then it’s time to understand how FDA views Part 11 today, how it enforces Part 11, and why compliance with 21 CFR 11 is an essential part of FDA compliance today.

    And yet, if you try to comply with Part 11 using outdated methodologies and “validate everything” interpretations, your costs will skyrocket and your risks will multiply. Part 11 compliance today requires a cost-effective, risk management mindset.

    Areas Covered In the Seminar

    Status of 21 CFR 11 (“Part 11”) today

    How FDA enforces Part 11 today

    Example investigator questions asked during inspections

    Recent enforcement citations and examples

    How to use risk management to narrow your scope and prioritize activities

    How to handle suppliers maintaining your data

    SOPs and policies you need to have

    How to avoid wasting money on validation

    Who will benefit

    Quality managers and professionals

    Validation managers and professionals

    IT managers and professionals

    Document control/records management professionals and managers

    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.