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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

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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 View Anytime
$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 View Anytime
$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 View Anytime
$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 View Anytime
$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 View Anytime
$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 View Anytime
$295.00

Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data.
Recorded View Anytime
$295.00

FDA Compliant HPLC Qualification and Performance Testing
Learn how to select, conduct and document the right tests in the right sequence.
Recorded View Anytime  Duration:60 Minutes
$295.00

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 View Anytime  Duration:75 Minutes
$295.00

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