Analytical Method Validation under Good Laboratory Practices (GLPs)

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 solubility 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.

Why You Should Attend:

This webinar will discuss the best practices of analytical method validation, including components of a validation, how to include critical reagents comparison, selectivity experiments, assessment of stability, and 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.

Areas Covered in the Session :

  • Method Validation
  • The criteria for a method
  • Statistical requirements
  • Documentation requirements
  • Maintaining Compliance
  • Common issues
Who Should Attend:

  • Analysts
  • Lab Supervisors and Managers
  • QA Managers and Personnel
  • Consultants
  • Validation Specialists
  • Chemists

FDB3460

Dr. John C. Fetzer

Dr. John C. Fetzer has been doing liquid chromatographic method development for over 35 years. His PhD was in studies of various types of chromatography. He has authored or co-authored over 50 papers on LC separations, has served on the advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry. He supervised the Good Laboratory Practices accreditation of a large research chromatography laboratory and has taught numerous short courses on GLP and ISO 17025 compliance.

membership

JUST RELEASED
SEMINARS
&
WORKSHOPS
 





  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.