MRO Magazine

Analytical Method Validation Under Good Laboratory Practices (GLPs) Webinar – Research and Markets

June 21, 2016 | By Business Wire News

DUBLIN

Research and Markets has announced the addition of the “Analytical Method Validation Under Good Laboratory Practices (GLPs) – Webinar” webinar to their offering.

Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices training (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 training. 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, environmental analysis is a pre-requisite. Each minor contaminant or degradation product is also important in GLP.

Discuss the best practices of analytical method validation, including components of a validation, how to include critical reagents comparison, selectivity experiments, assessment of stability, importance of communication between the development and the validation labs and accuracy of transfer documents (SOPs training).

Participants will understand – Is validation a regulated activity? When to pull the trigger for validation? Importance of suitability testing.

For more information visit http://www.researchandmarkets.com/research/nrm6jz/analytical_method

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
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Fax (outside U.S.): +353-1-481-1716
Sector: Pharmaceutical Manufacturing

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