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Tuesday, June 21 • 9:15am - 10:15am
#211: Shifting the Audit Paradigm for a More Effective Outcome

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-549-L04-P ; CME 1.00; RN 1.00

ICH E6(R2) and E8 (R1) require sponsors to focus on activities essential to the reliability and meaningfulness of study outcomes by identifying the critical to quality factors, associated risks and to review risk to determine effectiveness of QMS

Learning Objectives

Discuss how risk-based approach aligns with ICH; Describe key considerations for risk-based auditing; Identify the framework around the journey of moving from on-site audits to remote audits.

Chair

Stephanie Haley

Speaker

Industry Update
Jonathan Rowe, PhD, MA, MS

Quality Assurance and Auditing: The Regulatory Perspective
Jason Wakelin-Smith


Speakers
avatar for Stephanie Haley

Stephanie Haley

Director, CQA, Astellas, United States
Stephanie Haley has over 29 years of experience in pharmaceutical development which includes 21 years in Clinical Quality Assurance. Her professional experience also includes roles held in pre-clinical Histology, Data Management and Pharmacokinetics. Stephanie’s current role is... Read More →
avatar for Jonathan Rowe

Jonathan Rowe

Principal, Head of R&D Quality and Operations Risk Management, ZS, United States
Jonathan has >25 years in pharma developing medical therapies from clinical, operational, Quality and business perspectives. He is currently a Principal at ZS where he leads the Clinical Development Quality, Operations and Risk Management group. Previously, Jonathan held the position... Read More →

Tuesday June 21, 2022 9:15am - 10:15am CDT
Room 186 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  08: RD Quality-Compliance, Session