34th SQA Annual Meeting and Quality College

RQAP re-registration units: 2 GLP, GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
Chromatographic and mass spectrometric analyses provide critical data for many pharmacokinetic, dose analysis, safety, efficacy, and absorption, distribution, metabolism, and excretion (ADME) studies. Therefore, it is imperative that quality assurance professionals possess the knowledge and skills to properly audit this type of data. This course contains two distinct, but complimentary sessions. The morning session covers the theory and practice of high performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), gas chromatography (GC), and mass spectrometry (MS). We will discuss auditing techniques, system suitability testing, incurred sample reanalysis (ISR), and failure investigation. The afternoon session uses a problem based learning (PBL) approach to enhance and hone the quality assurance professional's skills for auditing chromatographic and mass spectrometric data. Participants will be placed into small teams and provided an example data and report packet to audit. We will then discuss the findings as a class. By combining background theory, practice, and applications with hands-on PBL, this course provides an all-around approach to auditing chromatographic and mass spectrometric analyses.

Objectives
At the end of the course, the participants shall be able to: 

• Identify different chromatographic techniques, their basic theory, and applications in a bioanalytical laboratory
• Discuss mass spectrometry, its theory and applications
• Define key chromatographic and mass spectrometry terms
• Provide guidance on failure investigations
• Use their newly gained understanding to better audit small molecule bioanalytical data

Target Audience
This course is for any quality assurance professional interested in understanding the science and auditing skills of bioanalytical chromatography and mass spectrometry. It will also cover incurred sample reanalysis and conducting failure investigations. This course is intended for beginner to intermediate level quality assurance professionals.

Agenda

• Topic Presenter Time (hr)
• Background (history) and types of chromatography
• Theory and practice of HPLC/UPLC/GC
• Auditing chromatographic data
• Theory and practice of mass spectrometry
• Auditing mass spectrometry data
• System suitability
• Incurred Sample Reanalysis (ISR)
• Failure investigations
• Lunch Break
• Topic Presenter Time
• Problem Based Learning, Hands-On Exercise