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    Ensuring 21 CFR 11 Compliance at Suppliers

    View: 114

    Website https://compliance2go.com/product/?topic=ensuring-21-cfr-11-compliance-at-suppliers-cp2015-463 | Want to Edit it Edit Freely

    Category Biotechnology , Medical Device , Pharmaceutical

    Deadline: July 21, 2015 | Date: July 21, 2015

    Venue/Country: Online, U.S.A

    Updated: 2015-06-29 17:46:49 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    Learn how FDA is enforcing 21 CFR 11 today, how it applies when you’ve hired a CMO or CRO, and how to put in place a cost-effective, risk-based Part 11 oversight program today. Learn the SOPs and policies to have, how to incorporate risk assessments, and how to tackle suppliers such as CROs, CMOs and hosted IT providers who maintain regulated records on your behalf.

    Areas Covered In the Seminar

    How 21 CFR 11 (“Part 11”) inter-relates with other FDA regulations

    Types of supplier-provided data FDA reviews under its Application Integrity Policy

    List of sampling methods FDA will accept when reviewing supplier-provided data

    Elements of a supplier-provided computer validation protocol that FDA will accept

    Red flags that indicate a supplier’s data integrity is failing

    Records to retain to show FDA that your supplier Part 11 oversight met FDA expectations

    FDA concerns of around your oversight of a supplier’s computer validation activities

    ips for when you are planning to outsource device production and/or clinical testing

    How to handle suppliers maintaining your data

    SOPs and policies you need to have

    Who will benefit

    Quality managers and professionals

    Validation managers and professionals

    IT managers and professionals

    Regulatory affairs managers and professionals

    Supplier quality professionals and managers

    Quality auditors

    Why you should attend

    Since 2010, FDA has embarked on a special enforcement and training of its investigators on both 21 CFR 11 and supplier controls. The result has been a rise in 483s and warning letters citing poor supplier management and poor data integrity.Will FDA believe the data from your suppliers is trustworthy?Part 11 is an easy way for an investigator to cite a firm for failure to comply with the QSRs and GMPs, especially when it comes to controlling supplier quality and recordkeeping.See how a supplier’s data integrity increasingly plays a critical role in proving compliance and proper oversight of purchased materials and services. And understand how FDA will delay or even deny a submission when it perceives that clinical trial data are untrustworthy.This webinar is intended for device makers who use CMOs or rely on contract services to store or process electronic data. Attendees will receive practical and easy-to-use information that converts warning letter cautions, FDA official statements, and investigator questions into real-world processes and valuable benefits. So if you don’t want to receive a Warning Letter from FDA citing you for data integrity issues ? or you don’t want to receive a 483 for poor supplier control ? then it’s time to understand how to ensure 21 CFR 11 compliance of your suppliers.

    Webinar Includes:

    Checklist of core Part 11 controls points to answer when qualifying a supplier

    Checklist of elements needed in a supplier’s computer validation plan

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    90 Minutes Live Presentation


    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.