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.

John C Fetzer
April 16 2025
01 : 00 PM EST
60 Minutes
The role of Logbooks and Recordkeeping in Identifying Root Causes
The records in a lab – the logbooks for chemicals, reagents, and calibration solutions, sample preparation, instrument maintenance and calibration, and quality checks – all are time-oriented. This gives a window of cause-and-effect or coincidence that can provide clues. The sum of these, plus the symptoms of the non-compliance, can point out the likely root cause.Learning ObjectivesTracking down the cause o..

John C Fetzer
May 08 2025
01 : 00 PM EST
60 Minutes
Calibration and accuracy under GLP
Accuracy, the ability for 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 ca..

John C Fetzer
June 09 2025
01 : 00 PM EST
60 Minutes
Statistical Process Control through the use of control charts and Nelson’s Rules
Control charts are based on the normal distribution of data expected in a laboratory operation, the Gaussian distribution of occurrences. There are well defined probabilities for the data. Whether it is the overall performance of a test method, the performance of a device or instrument, the behaviour of a calibration curve, the peak shapes in chromatography, or many other variables, the maintenance of good ..

John C Fetzer
July 22 2025
01 : 00 PM EST
60 Minutes
Dealing with Bad Data: Errors and Outliers in GLP
Assessment of the cause for 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 apparently anomalous data point, assessment of whether it really is an outlier using statistics are done. If so, asse..

John C Fetzer
August 05 2025
01 : 00 PM EST
60 Minutes
Low-level Compound Testing
Low-level compound analysis has many differences from that of the more common analyses aimed at major components. The requirements for accuracy and precision are different. Selectivity to differentiate very similar compounds, such as isomers of the various types – substituent positional, optical, and alkyl are some – becomes critical since these may differ in toxic effects.The need for definitive qualitativ..

John C Fetzer
Recorded Webinar
60 Minutes
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.Learning ObjectivesMany..

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..