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Tuesday, September 28 • 2:45pm - 3:45pm
TRACK A PANEL: Remote QA Best Practices

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Discuss Best Practices Learned During the Pandemic On Managing Clinical Quality Remotely   
  • Outline experiences with remote inspections and how this was executed from a technology standpoint
  • Identify challenges with remote site audits and remote study-level audits
  • Share thoughts on which QA practices may stay remote, even after the pandemic

Speakers
avatar for Michael Torok, Ph.D.

Michael Torok, Ph.D.

Senior Director, Clinical Quality Assurance, ASTELLAS
Michael Torok has over 20 years of experience in pharmaceutical development and has held leadership roles in Clinical Operations, Project and Portfolio Management, and Contracts and Outsourcing.  After completing coursework in data analytics and machine learning, Michael transitioned... Read More →
avatar for MyLe Hoang

MyLe Hoang

Senior Director, Clinical Quality Assurance, EISAI
MyLe Hoang has 22 years of experience in the pharmaceutical industry across various therapeutic areas with in-depth knowledge in clinical data management, trial management, clinical operations, process and quality management, GCP auditing and GCP inspections. MyLe is currently a senior... Read More →
avatar for Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP is an accomplished clinical quality and regulatory compliance professional with in-depth knowledge of all facets of clinical trial operations and the ability to support management and clinical teams that are conducting compliant clinical... Read More →
avatar for Lauren Hartman, RQAP-GCP

Lauren Hartman, RQAP-GCP

Director, Clinical Quality Assurance, FIBROGEN
A well-rounded, effective, personable and team-oriented quality assurance professional with 18 years of clinical research and development experience, having overseen the conduct of complex, global clinical trials in accordance with national regulations and GCP guidelines and performed... Read More →


Tuesday September 28, 2021 2:45pm - 3:45pm EDT