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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
Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part 11 Inspections
On July 8, 2010, the FDA announced to soon conduct a series of inspections related to 21 CFR Part 11.
Live  Thursday, September 9, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:75 Minutes
$245.00
...more

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
IT Infrastructure and Network Qualification - Introduction and Strategies for Compliance and System Uptime
Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA.
Recorded ,
$295.00
Good Laboratory Practice Regulations - Introduction and Strategies for Implementation
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations.
Recorded ,
$295.00
Handling OOS Test Results and Failure Investigations
No or inadequate procedures for handling out of specification (OOS) situations, failure investigations and corrective and preventive actions (CAPA) are amongst the most frequently found deviations in FDA warning letters.
Recorded ,
$295.00
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data.
Recorded ,
$295.00
Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part 11 Inspections
On July 8, 2010, the FDA announced to soon conduct a series of inspections related to 21 CFR Part 11.
Recorded ,
$295.00
...more