Ensuring 21 CFR 2014 - online webseminar on "Ensuring 21 CFR 11 Compliance at Suppliers" By compliance2go

DESCRIPTION
Description of the topic
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.
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
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.