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Wednesday, June 27 • 2:00pm - 3:15pm
#369: Virtual Audits: Do They Achieve the Objective?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-18-666-L04-P; CME 1.25; IACET 1.25; RN 1.25

The purpose of this session will be to bring industry together to discuss expectations and interpretation of recent risk-based guidance as applied to conducting audits remotely. Currently there are a number of large pharma/ biotech companies that, as part of their oversight obligations, perform audits, some of which are performed remotely. In some cases sponsors have received feedback from regulatory authorities regarding this methodology. Likewise, some regulatory authorities have been conducting GCP audits in a remote fashion (often termed desktop assessment). Case studies and other experience as to whether or not this audit format has served as a quality measure will be discussed.

Learning Objectives

Describe how industry professionals are applying risk-based methodology and employing technology to perform GCP audits without leaving their office; Explain how regulatory authorities are likewise performing (or are considering performing) inspections remotely and determine whether or not this is an acceptable practice to ensure quality oversight.

Chair

Sarah Ann Silvers, MS

Speaker

Industry Perspective
Sophie Moya

Industry Perspective
Kara Harrison, MS, RAC

Industry Perspective
Paul E Houri, MBA, MS


Speakers
avatar for Kara Harrison

Kara Harrison

Project Manager, FDA Quality and Regulatory Consultants
Kara started her career as a Field Investigator with the USFDA, concentrating in BIMO program inspections. Since leaving the agency she has had the opportunity to administer an IRB; work in academia, pharma, CROs; and consulting. Her areas of specialty include Agency inspection facilitation... Read More →
avatar for Paul Houri

Paul Houri

Vice President, Quality Assurance, Janssen Pharmaceutical Companies of Johnson & Johnson
Paul Houri is currently the Vice President, Head of BioResearch Quality Assurance at Johnson & Johnson leading a global team focused on execution of non-regulated, GLP, GCP and PV audits and quality activities. Paul has over 20 years of experience in quality and compliance related... Read More →
avatar for Sophie Moya

Sophie Moya

Quality Assurance Manager, Development, Medical, and Regulatory Affairs, Guerbet
Sophie Moya is Global Quality Assurance Manager for Development, Medical and Regulatory Affairs at Guerbet, responsible for activities related to quality assurance, risk analysis, audits and regulatory inspections. She has a post-graduate degree in Neurosciences, has studied Clinical... Read More →

Wednesday June 27, 2018 2:00pm - 3:15pm
Room 257AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: R and D Quality-Compliance, Session