Ensuring 21 CFR 11 Compliance at Suppliers by John Avellanet
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Website https://compliance2go.com/product/?pid=CP2014-374 |
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Category Biotechnology ;Medical Device ;Pharmaceutical
Deadline: February 25, 2015 | Date: February 26, 2015
Venue/Country: Online, U.S.A
Updated: 2015-01-26 16:13:07 (GMT+9)
Call For Papers - CFP
DESCRIPTIONLearn 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 SeminarHow 21 CFR 11 (“Part 11”) inter-relates with other FDA regulationsTypes of supplier-provided data FDA reviews under its Application Integrity PolicyList of sampling methods FDA will accept when reviewing supplier-provided dataElements of a supplier-provided computer validation protocol that FDA will acceptRed flags that indicate a supplier’s data integrity is failingRecords to retain to show FDA that your supplier Part 11 oversight met FDA expectationsFDA concerns of around your oversight of a supplier’s computer validation activitiesips for when you are planning to outsource device production and/or clinical testingHow to handle suppliers maintaining your dataSOPs and policies you need to haveWho will benefitQuality managers and professionalsValidation managers and professionalsIT managers and professionalsRegulatory affairs managers and professionalsSupplier quality professionals and managersQuality auditorsWhy you should attendSince 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 supplierChecklist of elements needed in a supplier’s computer validation planQ/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live Presentation
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