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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