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Speaker Profile
JOHN C FETZER

John C. Fetzer, has had over 30 year experience in laboratory compliance, including developing methods, writing SOPs, training, and auditing. He has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.


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$179.00
Method Validation Under Good Laboratory Practices (GLP)

 John C Fetzer
 October 20 2021
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
Method Validation Under Good Laboratory Practices (GLP)

Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees the validity of results. If you work in pharmaceuticals, chemicals, and petrochemicals, and environmental analyses then you are mandated to be following GLP. One of the major tasks in GLP is the validation of an analytical method.The new pharmaceutica..

Showing 1 to 9 of 9 (1 Pages)
$150.00
BEST SELLER - Method Validation of HPLC/ UPLC Methods

 John C Fetzer
 Recorded Webinar
 60 Minutes
 Download Catalog
BEST SELLER - Method Validation of HPLC/ UPLC Methods

Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.Instrumental liquid chromatography is an analysis that is widely used to determine purity, the..

$200.00
Analytical Method Validation And Transfer

 John C Fetzer
 Recorded Webinar
 90 Minutes
 Download Catalog
Analytical Method Validation And Transfer

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH, and USP have each recognized the impo..

$200.00
Determining a Rational HPLC/UHPLC Selectivity Starting Point

 John C Fetzer
 Recorded Webinar
 90 Minutes
 Download Catalog
Determining a Rational HPLC/UHPLC Selectivity Starting Point

Selectivity in a liquid chromatography (LC) separation is the ability to separate a molecule from other similarly structured compounds, such as conformational, positional, and optical isomers. Columns do this in a variety of ways that depend on the structural differences between the key target molecules. This is most commonly done by tailoring the column’s stationary phase so that the different target molec..

$200.00
Implementing a Quality Management System

 John C Fetzer
 Recorded Webinar
 60 Minutes
 Download Catalog
Implementing a Quality Management System

The Quality Management System (QMS) is a set of policies and protocols for the acceptable operation of an organization that contains laboratories that must comply with US FDA GLP. Examples of roles and responsibilities, useful metrics, and tools to monitor performance, and useful documentation will be given.Learning ObjectivesGLP RegulationsQuality Management System (QMS)DefinitionPrinciplesPurposeFunctionE..

$200.00
Issues in Calibrations and Accuracy in Method Validation

 John C Fetzer
 Recorded Webinar
 60 Minutes
 Download Catalog
Issues in Calibrations and Accuracy in Method Validation

Accuracy, the ability of a methodology to give results within acceptable limits when compared to known values, is a fundamental and key requirement. Calibration is the most common approach to obtain accuracy.Accuracy requires a comparison to a validated material. The level of confidence depends on traceability, a chain connecting the samples of interest all the way to the specific metric standards. This..

$200.00
Monitoring a Quality Laboratory to Prevent Non-Compliance

 John C Fetzer
 Recorded Webinar
 60 Minutes
 Download Catalog
Monitoring a Quality Laboratory to Prevent Non-Compliance

Everyone in a laboratory under compliance knows about 3-sigma out-of-control issues. Can the operation be monitored to avoid these? How? This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation to ensure that it is under control and to see when a problem is arising, but before it is outside of 3-sigma.Data quality and compli..

$200.00
The Transfer Of Validated Methods

 John C Fetzer
 Recorded Webinar
 60 Minutes
 Download Catalog
The Transfer Of Validated Methods

Even a detailed and well-written standard operating procedure for a method cannot ensure that 2 laboratories running on aliquots of the same will get statistically equivalent results. Using different instrumentation, standards, reagents, solvents, and other chemicals, data systems, sample storage, and handling procedures, and other variable is common and can lead to different results. Making each operation ..

$200.00
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

 John C Fetzer
 Recorded Webinar
 60 Minutes
 Download Catalog
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and quickly to be handled by adjustments rather than the strict s..

Showing 1 to 9 of 9 (1 Pages)