Houston, TX, July 12, 2012 --(PR.com
)-- Why you should attend
Since 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And yet, if you try to comply with Part 11 using outdated methodologies and “validate everything” interpretations, your costs will skyrocket and your risks will multiply.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.
Description of the topic
Learn 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.
Areas Covered In the Seminar
Status of 21 CFR 11 (“Part 11”) today
How FDA enforces Part 11 today
Example investigator questions asked during inspections
Recent enforcement citations and examples
How to use risk management to narrow your scope and prioritize activities
How to handle suppliers maintaining your data
SOPs and policies you need to have
How to avoid wasting money on validation
Who will benefit
Quality managers and professionals
Validation managers and professionals
IT managers and professionals
Document control/records management professionals and managers
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.”