Navigating The Capa Conundrum: Problem Statements and More
In the world of FDA-regulated quality management, CAPA (Corrective and Preventive Action) is a cornerstone process designed to identify, understand, resolve, and prevent issues or failures. However, despite its critical role in the FDA’s required approach to ensuring product quality, companies implementing these systems often encounter significant hurdles that can undermine their intended effectiveness. As […]
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 Quality Management System Regulation (QMSR) aims to harmonize FDA requirements for medical devices with international standards, particularlyc. This shift introduces new complexities, particularly in handling Corrective and Preventive Actions (CAPA). […]
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 corrective actions to address them and implement preventive measures to stop recurrence. With distressing regularity, though, many organizations find themselves caught in a riptide of CAPAs. They are slowly taken […]
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 operations. The training also discusses drug, biologics, and combination product GMP requirements for “virtual” companies. Company sponsors must comply with regulatory standards when outsourcing manufacturing for clinical materials, APIs, drug […]
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 are trained, and all documentation is complete. But firms also need to be well-prepared for how to handle it when the FDA does have observations during an inspection. Preparation requires […]
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 other outstanding experts on the Essentials of Post-Inspection Actions: From FDA Notices to Criminal Prosecution. This program is part of FDLI’s Summer Learning Series, and will be an exceptionally important […]
