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Virtual Audits: Do They Achieve the Objective?
Session Chair(s)
Sarah Ann Silvers, MS
Head of Clinical QA
Orca Bio, United States
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 Objective : 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.
Speaker(s)
Industry Perspective
Sophie Moya
Guerbet, France
Quality Assurance Manager, Development, Medical, and Regulatory Affairs
Industry Perspective
Kara Harrison, MS, RAC
FDA Quality and Regulatory Consultants, United States
Project Manager
Industry Perspective
Paul E Houri, MBA, MS
Janssen Pharmaceutical Companies of Johnson & Johnson, United States
Vice President, Quality Assurance