In December 2010 the FDA began a project to better understand the industry's adherence (or lack thereof) to 21 CFR Part 11. This involves the 'add on' surveillance inspections of the sponsors' computer systems during the course of the FDA's regular inspections. This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11.
Why should you Attend
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations. This webinar will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Areas Covered in the Session:
What is FDA's most current thinking related to computers and electronic records?
What are the inspection trends?
What are most frequent recent citations for Part11?
What are the most frequent deviations for computer system validation?
Under which circumstances can inspectors exercise enforcement discretion?
How important is risk based Part11 compliance?
What is the best strategy for future proven Part 11 compliance?
Who will Benefit:
Everybody using computers in FDA regulated environments
IT manager and staff
QA managers and personnel
Regulatory affairs
Training departments
Consultants
Validation specialists
Why should you Attend
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations. This webinar will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Areas Covered in the Session:
What is FDA's most current thinking related to computers and electronic records?
What are the inspection trends?
What are most frequent recent citations for Part11?
What are the most frequent deviations for computer system validation?
Under which circumstances can inspectors exercise enforcement discretion?
How important is risk based Part11 compliance?
What is the best strategy for future proven Part 11 compliance?
Who will Benefit:
Everybody using computers in FDA regulated environments
IT manager and staff
QA managers and personnel
Regulatory affairs
Training departments
Consultants
Validation specialists
