A Playbook for FDA Inspections and Remediation with Jeff Hines скачать в хорошем качестве

A Playbook for FDA Inspections and Remediation with Jeff Hines

Coruna Medical’s Vice President of Quality, Jeff Hines, joins host Nick Capman to share a leadership-driven playbook for navigating FDA remediation—without overwhelming teams or losing focus on long-term improvement. Drawing from nearly four decades in pharmaceutical quality, including more than 30 years at Eli Lilly, Jeff offers practical guidance for building calm, effective inspection environments and keeping people confident under pressure. He outlines the four-room model for inspection management, strategies for responding to observations, and proven methods for closing data-integrity gaps while daily operations continue. Jeff and Nick also explore the leadership mindset that sustains progress beyond the initial response—fostering transparency, prioritization, and a culture of accountability that prevents repeat findings. Topics discussed include: The leadership posture that steadies teams during inspections and remediation How to stand up the four-room inspection model (Front, Back, Doc-QC, SME-Prep) Responding to 483s: when to push, when to accept, and how to align internally Data-integrity vulnerabilities and effective interim controls Balancing remediation with production demands Building transparency and accountability into quality culture Keeping systems current to avoid backsliding into repeat observations About The FDA Group: The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: ⁠⁠https://www.thefdagroup.com/