HPLC Analytical Method Development and Validation

[Joseph Wilcox]

Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, will organize a webinar on the topic of HPLC Analytical Method Development and Validation, on February 21. John Fetzer, a senior professional in HPLC methods, will be the speaker at this session.

Please visit http://bit.ly/2SEmev3 to enroll for this webinar and gain insights into the core aspects of how to carry out HPLC methods in a manner that meets the requirements set out by the regulatory agencies such as the FDA and the EPA.

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Instrumental liquid chromatography is an analysis used widely in the field of pharmaceuticals to determine purity, the impurities, and the degradation of products. While the Standard Operating Procedure (SOP) is the area on which most validation work gets focused; this is not the only one. Auditors also look for other areas, such as validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals.

A means for meeting regulatory standards

A method must pass many stringent requirements if it has to meet the requirements set out by the EPA in Europe or the FDA in the US, it. What happens to organizations that fail to do so? They are seen to be noncompliant, a state in which no data is usable or reportable. Obviously, avoiding being in this state should be the aim of all pharmaceutical organizations.

A webinar to help understand how to be compliant

This webinar from Traininng.com will shed light on the methods that pharmaceutical organizations can adapt to achieve standards that both meet regulatory compliance requirements, as well as fulfil the demands of auditors. The main learning that this webinar’s expert, John Fetzer will impart will consist of method validation and instrument validation for specific analytical methods, two of the more important ways of meeting the prescribed regulatory standards and to satisfy auditors.

Chemists and laboratory assistants who perform High Performance Liquid Chromatography (HPLC) or Ultra Performance Liquid Chromatography (UPLC) analyses under GLP or ISO 17025 will benefit hugely from this webinar.

These are the areas that will be covered at this webinar:

• Instrument validation
  • The pumping system
  • The column
  • The detection system
  • The Data System
• Method validation
  • Accuracy
  • Precision and the various measures of precision (repeatability, reproducibility, ruggedness, robustness)
  • Limits of detection and quantitation, linearity
  • Selectivity, interferences, and specificity
  • Sensitivity
  • Solution stability

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About the speaker: The highly experienced John C. Fetzer has authored or co-authored over 50 peer-reviewed papers on liquid chromatography in the three decades and more for which he has been working as an HPLC professional.  During this tenure, John has also served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.http://bit.ly/2SEmev3