For today’s regulatory professionals, continuous audit readiness is essential. With evolving standards like ICH E6 (R3) and increased global scrutiny, being inspection-ready every day ensures compliance is not left to chance. It strengthens documentation practices, mitigates the risk of costly findings, and reinforces patient safety — all while positioning you as a proactive partner to both regulators and your organization.

At this free webcast, former US Food and Drug Administration (FDA) inspectors Chris Rush and Randall Morris will discuss quality-based risk management for sponsors and tools a company might use to focus on continuous inspection readiness.

Learning Objectives

Participants will understand:

• What is quality-based risk management?
• Why is it important
• What happens when quality-based risk management practices are not followed
• The true cost of non-compliance
  
  

Who Should Attend?

RAPS members working in the Good Clinical Practice (GCP) space should plan to attend this session that have an intermediate skill level.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Speakers

Randall Morris
Inspection Readiness Advisor/GCP Auditor, FDA Quality and Regulatory Consultants, LLC

Randall Morris has worked in clinical care, clinical research, conducting inspections/audits, and regulatory affairs. He has worked as a clinical nurse, clinical research nurse, clinical research coordinator, FDA investigator, and FDA compliance officer, and his experience includes conducting many FDA investigator site audits and review of numerous cases as a compliance officer. Randall earned his master’s of science in nursing-clinical research management from Duke University and undergraduate degree in Nursing from Old Dominion University. Randall joined FDA QRC in 2019.

Chris Rush
President, FDA Quality and Regulatory Consultants, LLC

Chris Rush has inspected over 50 facilities, including pharmaceutical and bioresearch monitoring (BIMO) inspections, while working for FDA. Chris was a member of the International Inspection Cadre and participated in six inspections in Turkey, Bulgaria and Germany. He was presented with the U FDA Group Recognition Award, the US Food and Drug Administration Leveraging/Collaboration Award in May 2004 and the US FDA Outstanding Service Award in May 2006. Chris took leave from the US FDA in 2007 and took his regulatory and inspection knowledge to a global IVD manufacturer where he worked as a project manager for Class II/III IVD devices. There, his responsibilities included clinical trial monitoring, FDA submission and follow-up correspondence. Chris authored two 510k applications that were cleared by the FDA and assisted in the clearance of multiple other 510(k)s. His experience transitioned well to a global pharmaceutical company where he conducted clinical QA audits, including routine and for cause audits that included all audit activities to assess compliance to established practices/standards and established regulations. He earned his MBA from North Texas University. Chris founded FDA QRC in 2009.