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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
How to Deal with Bad Results Under GLP

 John C Fetzer
 July 26 2019
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
How to Deal with Bad Results Under GLP

Assessment of the cause of a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.In the case of an apparent anomal; ous data point, assessment of whether it really is an outlier using statistics are done. If so, asses..

$179.00
Writing and Implementation of Good Standard Operating Procedures (SOPs)

 John C Fetzer
 July 29 2019
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
Writing and Implementation of Good Standard Operating Procedures (SOPs)

An SOP can be the cause of numerous non-compliance citations during an audit. Each can lead to other non-compliances so that each SOP can be either a solid footing or building the laboratory’s work on quicksand. Writing a good SOP is not difficult, but it is time-consuming. Documentation and reviews must be made. Responsibilities for implementation and maintenance must be laid out. Recordkeeping must be don..

$179.00
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

 John C Fetzer
 August 23 2019
 01 : 00 PM EST    
 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)
$200.00
Quality by Design (QbD) for Analytical Methods

 John C Fetzer
 Recorded Webinar
 60 Minutes
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Quality by Design (QbD) for Analytical Methods

This 60-minute presentation will highlight the use of statistical tools to monitor operations for a proactive operation.There are always certain steps in a method where control is critical either because this step contributes a lot to the overall uncertainty or its uncertainty is more likely to change from common causes. These critical points can be assessed and a monitoring program instituted. This data is..

$200.00
Method Validation of HPLC/ UPLC Methods

 John C Fetzer
 Recorded Webinar
 60 Minutes
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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 is widely used to determine purity, the impu..

$200.00
Issues In Calibrations And Accuracy In Method Validation

 John C Fetzer
 Recorded Webinar
 60 Minutes
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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 can..

$200.00
Validation of GC/ GC-MS methodologies

 John C Fetzer
 Recorded Webinar
 60 minutes
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Validation of GC/ GC-MS methodologies

Instrumental gas chromatography, either as GC or GC-MS, 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 gas chromatography is an analysis is widely used to determine purity, the impurities,..

$200.00
Monitoring a Quality Laboratory to Prevent Non-Compliance

 John C Fetzer
 Recorded Webinar
 60 Minutes
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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
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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 are common and can lead to different results. Making each operation..

Showing 1 to 9 of 9 (1 Pages)