Call us: +1-855-202-3299
Email: [email protected]
Speaker: John C. Fetzer
Speaker Designation: Founder and Principal, Consultant Fetzpahs Consulting
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 validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.
In order to meet US EPA or FDA requirements, a method must meet many stringent requirements. The more important of these for specific analytical methods are method validation and instrument validation. To not do so is a non-compliance in which any data is not usable or reportable.
Participants will gain insights into the key considerations and challenges associated with method development and validation, as well as practical strategies for optimizing method performance and ensuring regulatory compliance.
High-Performance Liquid Chromatography (HPLC) is a powerful analytical technique widely used in pharmaceutical, chemical, and biotechnology industries for the quantitative analysis of compounds. The development and validation of HPLC analytical methods are critical steps in ensuring the accuracy, reliability, and reproducibility of analytical results.
Dr. Fetzer has had many roles in compliance under Good Laboratory Practices and ISO 17025. He developed liquid chromatography and physical-property assays for a variety of compounds. He supervised a compliant laboratory for over a decade. He has performed outside audits for "mock" compliance audits. He has been training in this topical area for many years.
Dr. Fetzer's expertise extends beyond academia, having published over 100 peer-reviewed scientific articles, 2 books, and 8 book chapters. He was key in overseeing the Good Laboratory Practices accreditation for a prominent research chromatography laboratory. Additionally, Dr. Fetzer has shared his knowledge by conducting numerous short courses on GLP and ISO 17025 compliance.
Beyond his contributions to the scientific community, Dr. Fetzer offers Analytical Chemistry Consulting Services and Scientific Career Development Consulting services. As an American Chemical Society tour speaker, he has delivered over twenty invited lectures at conferences, universities, and government laboratories, further solidifying his impact in the field.
