Analytical Method Validation Under Good Laboratory Practices (GLP) Live Webinar

Overview

Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees validity of results. If you work in pharmaceuticals, chemicals and petrochemicals, and environmental analyses then you are mandated to be following GLP. One of the major tasks in GLP is validation of an analytical method.

The new pharmaceuticals are very often completely new compounds, structures never studied before by chemists. Their properties – such as solubilities and acid-base nature, are unknown. Synthetic reactions may make many similar types of molecules, including structural and optical isomers. The methodologies that mean US Food and Drug Administration compliance with GLP require a separation to be able to separate and identify all major, minor, and trace components. It is no longer just determining a purity of the main component. Each minor contaminant or degradation product is also important in GLP.

This analytical method validation webinar will provide practical tips on how to validate an analytical method under the GLP requirements. It is recommended for laboratories that are under, or want to be under, Good Laboratory Practices (GLP).An overview of method validation, the criteria to be met, the role of the standard-operating procedure, and the use of statistics to assess compliances

Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees validity of results. If you work in pharmaceuticals, chemicals and petrochemicals, and environmental analyses then you are mandated to be following GLP. One of the major tasks in GLP is validation of an analytical method.

The new pharmaceuticals are very often completely new compounds, structures never studied before by chemists. Their properties – such as solubilities and acid-base nature, are unknown. Synthetic reactions may make many similar types of molecules, including structural and optical isomers. The methodologies that mean US Food and Drug Administration compliance with GLP require a separation to be able to separate and identify all major, minor, and trace components. It is no longer just determining a purity of the main component. Each minor contaminant or degradation product is also important in GLP.

This analytical method validation webinar will provide practical tips on how to validate an analytical method under the GLP requirements. It is recommended for laboratories that are under, or want to be under, Good Laboratory Practices (GLP).

Webinar Takeaway

Topic 1 Regulatory Requirements/ Guidance on Analytical Method Validation

• Types of US Food & Drug Applications
• FDA Guidance
• Defining the Report
• Defining the Report Content

Topic 2 Analytical Method Pre-validation

• Analytical Target Profile
• Questions of the Analytical Target
• Factors Influencing Quality of Measurements

Topic 3 Analytical Method Validation Characteristics

• Analytical Method Validation
• Possible Criteria

Topic 4 Method Validation Protocol

• What is method validation?
• Reminder: Analytical Target Profile

Topic 5 The Method Validation Report

• Reiterating, the FDA defining the Report
• The Report

Questions and discussion?

Who Will Benefit

This webinar will provide valuable assistance to the following personnel from regulated laboratories in pharmaceuticals, chemicals and petrochemicals industry:

• Analysts
• Lab Supervisors and Managers
• QA managers and personnel
• Consultants
• Validation Specialists
• Chemist