Why Should You Attend:
Some time ago, FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 related issues being part of most inspection. 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 key findings, and inspectors regularly cited deviations related to computer validation and other Part 11 issues. Due to lack of clear guidance from the FDA, the industry has lots of questions. Using recent warning letters as examples, this webinar will demonstrate how current Part 11 requirements will be met.
Backed by strong, informative content on the subject, attendees will enjoy the advantage of detailed instruction on the subject and addressing frequently asked industry queries on the topic as well.
Areas Covered in the Webinar:
FDA inspections - preparation, conducts, follow up
The meaning of Warning Letters and 483 inspectional observations
Learning from an FDA presentation: Data Integrity and Fraud - Another Looming Crisis?
Data integrity and authenticity: FDA's new focus during inspections
Examples of recent Part 11 related 483s and Warning Letters
Examples of recent 483s and Warning Letters related to computer system validation
Most obvious reasons for deviations
Avoiding and responding to 483s: going through case studies
Writing corrective and preventive action plans as follow up to 483s
Using internal audits to prepare yourself for Part 11 related FDA inspections
Strategies and tools for compliant Part 11 implementation
The future of Part 11 and computer system validation
Some time ago, FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 related issues being part of most inspection. 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 key findings, and inspectors regularly cited deviations related to computer validation and other Part 11 issues. Due to lack of clear guidance from the FDA, the industry has lots of questions. Using recent warning letters as examples, this webinar will demonstrate how current Part 11 requirements will be met.
Backed by strong, informative content on the subject, attendees will enjoy the advantage of detailed instruction on the subject and addressing frequently asked industry queries on the topic as well.
Areas Covered in the Webinar:
FDA inspections - preparation, conducts, follow up
The meaning of Warning Letters and 483 inspectional observations
Learning from an FDA presentation: Data Integrity and Fraud - Another Looming Crisis?
Data integrity and authenticity: FDA's new focus during inspections
Examples of recent Part 11 related 483s and Warning Letters
Examples of recent 483s and Warning Letters related to computer system validation
Most obvious reasons for deviations
Avoiding and responding to 483s: going through case studies
Writing corrective and preventive action plans as follow up to 483s
Using internal audits to prepare yourself for Part 11 related FDA inspections
Strategies and tools for compliant Part 11 implementation
The future of Part 11 and computer system validation
