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The Annual Meeting program is subject to change. Speakers are added as confirmations are received.
Please  note that Quality College workshops require separate registration.

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Friday, April 13 • 8:00am - 5:00pm
Workshop 21 - General 106: Auditor's Primer: Chromatography & Mass Spectrometry (1 day)

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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


Speakers
avatar for Charlie Kirsch

Charlie Kirsch

QA Auditor II, PPD, Inc.
Charlie Kirsch, RQAP-GLP currently has a position as a QA Auditor II at the PPD, Inc. Bioanalytical Laboratory located in Middleton, WI. After receiving his Bachelor of Science degree from Virginia Commonwealth University, he began his career in Richmond, VA at PPD, Inc., in 2009... Read More →
avatar for Deborah Parker

Deborah Parker

QA Manager, ICON Bioanalytical Laboratories
Deborah Parker is a QA Manager at ICON PLC. She has over three decades of experience in the pharmaceutical industry, with training as a bioanalytical scientist. Having performed analysis using RIAs, Enzyme Inhibition testing, ELISAs, HPLC and LC-MS/MS, her background provided a perfect... Read More →
avatar for Steve Rogenthien

Steve Rogenthien

Director, Quality Assurance, Concord Biosciences/Frontage Laboratories
Mr. Rogenthien is the QA Director at Concord Biosciences, LLC (formerly Ricerca Biosciences) where he oversees the quality programs that support the company's drug safety & metabolism, bioanalytical, and agrochemical product development departments. Prior to joining Ricerca in 2007... Read More →
avatar for Kim Wheeler

Kim Wheeler

QA Manager, PPD
Ms. Wheeler started in GLPs in December of 1980 at A.H. Robins Research. She has over 10 years’ experience in analytical method development in GLPs /GMPs, having worked for Robins Research Division and Sergeant’s Pet Products.Kim Wheeler is a MLT-AD, ASCP, and managed a hospital... Read More →


Friday April 13, 2018 8:00am - 5:00pm
Platinum 9

Attendees (3)