Analytical Method Validation under Good Laboratory Practices (GLPs)

Duration: 70 Minutes
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) with FDA compliance training.
Analytical Method Validation Under GLPs
Instructor: John Fetzer
Product ID: 501410
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated; the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Objectives of the Presentation
  • Method Validation
  • The criteria for a method
  • Statistical requirements
  • Documentation requirements
  • Common issues
Why Should you Attend
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.

Areas Covered
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.

Who can Benefit
  • Analysts
  • Lab Supervisors and Managers
  • QA Managers and Personnel
  • Consultants
  • Validation Specialists
  • Chemists
$375
Recorded Session for one participant
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How it works
Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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.
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