FDA's 21 CFR 11 Add-On Inspections - Recent Updates
Short course
Online
*Indicative price
Original amount in USD:
$ 150
Description
-
Type
Short course
-
Level
Advanced
-
Methodology
Online
-
Class hours
2h
-
Duration
1 Day
-
Start date
October
-
Virtual classes
Yes
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.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Knowledge
- Compliance Trainings
- Healthcare
- Medical courses
- Online Trainings
- Compliance education
- Industrial courses
- Technical courses
- Fda inspections
- Financial updates
Teachers and trainers (1)
Adam Fleming
Event Manager
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements.
Course programme
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 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. This 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.
Why should you Attend: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. This Webinar will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company and the industry, and provide guidance on how your company can ensure that they have a successful inspection.
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?
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
Additional information
FDA's 21 CFR 11 Add-On Inspections - Recent Updates
*Indicative price
Original amount in USD:
$ 150