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Nice response to my questions and good suggestions for moving forward.

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.


 Speaker Profile


Dr. Ludwig Huber
Chief Advisor - Global FDA compliance, Agilent Technologies

Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.

 Upcoming Webinars
No Live Webinars found.
 Recorded Webinars
FDA's New Enforcement of 21 CFR Part 11
FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations.
Recorded  Wednesday, April 7, 2010 10:00 AM PST | 01:00 PM EST,  Duration:75 Minutes
$295.00

FDA Compliant HPLC Qualification and Performance Testing
Learn how to select, conduct and document the right tests in the right sequence.
Recorded  Thursday, March 4, 2010 10:00 AM PST | 01:00 PM EST,  Duration:60 Minutes
$295.00

Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Recorded ,
$295.00

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Recorded ,
$295.00

...more


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