Ensuring 21 CFR 11 Compliance At Suppliers
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.
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
- Tips 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.
About Speaker
John Avellanet is an award-winning FDA compliance expert.
He serves as the IRO for a major consent decree, is the lead author of several certification courses for the US Regulatory Affairs Professional Society, and has recently published the book Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (Logos Press).
In 2009 and 2011, Mr. Avellanet won the “Best of Business” award from the US Small Business Commerce Association. His blog, ComplianceZen.com, has been repeatedly named one of the “Top 50 Blogs” worldwide on FDA compliance issues.
Over the past 6 years, he has been interviewed on public radio programs and in numerous industry magazines. He speaks frequently for industry conferences and corporate workshops.
Prior to founding his lean compliance consulting firm, Cerulean Associates LLC, Mr. Avellanet was a former Fortune 50 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, DEA, BIS and FDA compliance. During his career, he had to defend decisions to investigators, auditors, and litigators alike. He now brings all of that hard-won, real-world experience and practical advice to his corporate clients worldwide. To date, he has saved his clients an average of $1.2 million each and kept them out of trouble with FDA, EMA and other regulatory agencies.
A former US Department of Justice prosecutor has said of Mr. Avellanet, “He is the best in the business. Period.”