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And yet, if you try to comply with Part 11 using outdated methodologies and "validate everything” interpretations, your costs will skyrocket and your risks will multiply.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
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance
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And yet, if you try to comply with Part 11 using outdated methodologies and "validate everything” interpretations, your costs will skyrocket and your risks will multiply.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
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance
