Navigating the QMSR Transition: Aligning CAPA Processes with ISO 13485 and FDA Requirements
Navigating regulatory compliance often feels like traversing a labyrinth filled with standards and requirements that demand precision and vigilance. The FDA’s upcoming transition to the
Caught in a CAPA Riptide? Navigate Your Way to Effective CAPA Management!
CAPA (Corrective and Preventive Actions) are at the heart of any sound quality management system. By definition, CAPA processes ensure that you identify nonconformances, take
GxP Best Practices Part 3: GMP Compliance in Outsourced Manufacturing
In session 3 of the Executive GxP Training, Teresa Gorecki and Jamie Colgin discuss how GMP compliance applies to companies that have outsourced all manufacturing
Mastering FDA Inspection Readiness: Key Strategies for Compliance Success
FDA inspection readiness is always a hot topic within the life sciences industry. Much attention is paid to ensuring that SOPs are in place, employees
Essentials of Post-Inspection Actions: From FDA Notices to Criminal Prosecution | August 18, 2022 | 2:00–3:30 PM ET | Live Webinar | FDLI
Attention life science quality and compliance professionals. Mark your calendars for this Thursday, August 18th at 2PM ET! Our colleague Teresa Gorecki is presenting with four