Live Online Training FDA’s Part 11 ? Enforcement Trends and Affordable Steps to Take Today
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Website https://compliance2go.com/product/?pid=CP2014-371 |
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Category Biotechnology , Medical Device , Pharmaceutical
Deadline: January 13, 2015 | Date: January 13, 2015
Venue/Country: Houston, U.S.A
Updated: 2014-11-21 16:38:04 (GMT+9)
Call For Papers - CFP
DESCRIPTIONLearn 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 attendSince 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compliance with 21 CFR 11 is an essential part of FDA compliance today.And yet, if you try to comply with Part 11 using outdated methodologies and “validate everything” interpretations, your costs will skyrocket and your risks will multiply.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 SeminarStatus of 21 CFR 11 (“Part 11”) todayHow FDA enforces Part 11 todayExample investigator questions asked during inspectionsRecent enforcement citations and examplesHow to use risk management to narrow your scope and prioritize activitiesHow to handle suppliers maintaining your dataSOPs and policies you need to haveHow to avoid wasting money on validationWho will benefitQuality managers and professionalsValidation managers and professionalsIT managers and professionalsDocument control/records management professionals and managersWebinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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