Dr.John Fetzer

Under GLP only the occurrence of a 3-sigma result is used as a statistical sign for bad performance. There are several others that are based on trends in data behaviors, such as non-randomness and a change in the spread of the data distribution. These trends w ...

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 ...

Instrumental gas chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation ...

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validat ...

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 t ...

Method validation involves assessing the results of an analytical methodology to prove that it meets all of the requirements that its output, the data, must have. This two-hour presentation covers the intentions of method validation, several of the common crit ...

This webinar will discuss the best practices for the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Control charts are based on the distribution of data expected in a laboratory, the Gaussian distribution of occurrences. There are well defined probabilities for the data. Guidelines for good or unacceptable behaviour are well known. The most common of these a ...

Instrumental liquid chromatography is an analysis widely used to determine purity, impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of ...

This webinar will discuss the best practices for the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.