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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.

Please review the Safety Rules and Guidelines.
Thursday, April 12 • 1:30pm - 5:30pm
Workshop 14 - General 103: The Biologics Super Highway (1/2 day)

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RQAP re-registration units: 1 non-GCP, non-GLP

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

Description
Provide an overview of the science behind Ligand Binding Assays used in regulated bioanalysis. The course will cover both PK and ADA assays, and describe some of the areas where auditors should focus their review.

Objectives
At the end of the course, the participants shall be able to: 
  • Overview of the science of ligand binding assays (LBAs)
  • PK LBAs
  • ADA LBAs
  • Bioequivalence vs. Biosimilars
  • Biomarkers

Target Audience
Auditors new to bioanalysis and new to auditing large molecules.

Agenda
  • Overview of the science of ligand binding assays (LBAs)
  • PK LBAs
  • ADA LBAs
  • Bioequivalence vs. Biosimilars
  • Biomarkers


Speakers
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 Lucy Podbielski

Lucy Podbielski

Associate Director, Toxicology Lab Sciences QA, Charles River Laboratories
Lucy Podbielski is Associate Director, Toxicology Lab Sciences QA, Charles River. She has over 20 years of experience in bioanalytical labs, starting as an analyst and transitioning to QA in 2009. She manages the Toxicology Laboratory Science Good Laboratory Practice Quality Assurance... Read More →


Thursday April 12, 2018 1:30pm - 5:30pm
Platinum 3&4

Attendees (7)