Source: http://www.labcompliance.com/seminars/audio/344/default.aspx
Timestamp: 2017-06-24 17:23:15
Document Index: 120921049

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Recent Warning Letters Related to Computer Validation and Part 11
1) Edwin Rivera: Data Integrity and Fraud – Another Looming Crisis? 2) George Smith: Update on Part 11 3) George Smith: Risk based computer system validation
Testimonials for the presenter's Part 11 seminars
On-line Audio Seminar 344
Learning from Recent Warning Letters related to Part 11 and Computer Validation With Clear Recommendations for Corrective and Preventive Actions
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 many 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 and inspectors regularly cited deviations related computer validation and other Part 11 issues. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations. Because of missing clear guidance the industry has lots of questions
What are most frequent recent citations related to electronic records?
When and how to best respond to 483's to avoid warning letters?
Why do most responses to 483's and Warning Letters fail?
Are there proven tools that help to implement strategies?
Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present examples and recommendations on how to avoid Part 11 related FDA warning letters and 483's. After the seminar, an extensive list of reference material like case studies on how to avoid or respond to 483's, SOPs, checklists and templates will help immediate and cost effective implementation of a Part 11 program that is in line with current and future FDA's expectations. The seminar lasts one hour and will be conducted over the phone and supported by the Internet.
Data integrity and authenticity: FDA's new focus during inspections Examples of recent Part 11 related 483’s and Warning Letters
Six example SOPs: - FDA Inspections: Preparation, conduct, follow up
- Integrity and Security of Electronic Data
- Review of Electronic Audit Trail
Checklists: - Part 11 compliance
- Security and Integrity of Electronic Data
- Checklist: Electronic Audit Trail
FDA Presentations: - Edwin Rivera: Data Integrity and Fraud - Another Looming Crisis?
QA managers and personnel Quality control directors or delegates
estimonials/References
Audio Seminar : Learning from Recent FDA Warning Letters Related to Computer Systems and Part 11
Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 Feedback: I basically wanted a overview of what the FDA is looking for and this webinar fit my needs exactly. I thought the presentation of the material was done very well, DR Huber is obviously knowledgeable and he presented the subject matter very clearly.