Written by: Patti Rossman Preparing for a REMS (Risk Evaluation and Mitigation Strategies) audit can be a daunting task, but with the right approach, it can be manageable and even straightforward. Whether you are a vendor or a service provider, ensuring compliance with REMS requirements is crucial for maintaining regulatory standards and delivering quality services.
Category: Auditing
Staying Ahead: Navigating Timely Training and Version Control in Pharmaceuticals and Medical Devices
written by: Jenny Azarh In the dynamic world of Pharmaceuticals and Medical Devices, maintaining regulatory compliance and ensuring the highest standards of quality is crucial for ensuring patient safety. Throughout 2023, Globiox auditors conducted over 40 quality audits, revealing a recurring issue within the industry: overdue training and delayed training acknowledgments. This common challenge underscores
High frequency of CAPA related observations in warning letters
Globiox proactively monitors FDA inspection trends by reviewing and analyzing the contents of the Warning Letters. A current trend we detected is the high frequency of observations related to Corrective and Preventive Actions (CAPA) in Warning Letters. Out of 43 Warning Letters issued to Medical Device companies (since March 22, 2013), 29 have contained observations relating