In the field of pharmaceuticals, instrumental liquid chromatography is an analysis widely used to determine purity, the impurities, and the degradation of products. The Standard Operating Procedure (SOP) is the area on which most validation work is focused. However, auditors look for other areas, such as validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals.
Meeting regulatory standards
If a method has to meet the EPA or FDA requirements in the US, it must meet many stringent requirements. Failing to do so results in non-compliance, a state in which no data is usable or reportable.
This is a state all pharmaceutical organizations must strive to avoid. Method validation and instrument validation for specific analytical methods are among the more important ways of meeting the prescribed regulatory standards and to satisfy auditors.
A webinar to help understand this
The ways by which pharmaceutical organizations can achieve standards that both meet regulatory compliance requirements, as well as fulfil the demands of auditors, will be the learning that a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will impart. To enroll for this webinar, just visit http://www.compliance4all.com/control/w_product/~product_id=501042.
The speaker at this webinar is the highly experienced and acclaimed John C. Fetzer. During the over 30 years he has spent in HPLC methods development; John has authored or co-authored over 50 peer-reviewed papers on liquid chromatography and has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.
Chemists and laboratory assistants who perform High Performance Liquid Chromatography (HPLC) or Ultra Performance Liquid Chromatography (UPLC) analyses under GLP or ISO 17025 will derive immense benefits 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
- Precision and the various measures of precision (repeatability, reproducibility, ruggedness, robustness)
- Limits of detection and quantitation, linearity
- Selectivity, interferences, and specificity
- Solution stability