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Analytical Method Validation under
Good Laboratory Practices (GLPs)
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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.
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.
Description:
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives of the Presentation:
Method Validation
The criteria for a method
Statistical requirements
Documentation
requirements
Common issues
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit:
Analysts
Lab Supervisors and Managers
QA Managers and Personnel
Consultants
Validation Specialists
Chemists
Track this Link:
Good Laboratory Practices (GLPs)
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

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Analytical method validation under good laboratory practices (gl ps)

  • 1. Analytical Method Validation under Good Laboratory Practices (GLPs) www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 2. 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. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 3. 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. 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. Description: www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 4. Objectives of the Presentation: Method Validation The criteria for a method Statistical requirements Documentation requirements Common issues www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 5. 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. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 6. Who can Benefit: Analysts Lab Supervisors and Managers QA Managers and Personnel Consultants Validation Specialists Chemists Track this Link: Good Laboratory Practices (GLPs) www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com