Regulated CGMP companies must develop / implement a formal CSA, Computer Software Assurance program, addressing AI where appropriate, per the FDA's recent Guidance Document. Software and related hardware design, development, verification and validation is dif ...
In this training you will discover the secret skills used by top therapists to deal with the most challenging of people. From annoying people at work … All the way to lock-down psychiatric patients. These skills are all extensively tested in the field and know ...
This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks. Participants will learn systematic approaches to identify root causes, develop effe ...
This webinar will examine the existing requiements for the US FDA's DHF -- including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and it's Technical Documentation File requirem ...
Artificial Intelligence (AI) is rapidly becoming part of daily operations in GMP-regulated industries, from automated documentation reviews and predictive analytics to deviation investigations and training systems. While many organizations are still exploring ...
When difficult employee behavior is not addressed properly, other employees become resentful, they lose respect for your organization’s leaders, and they start modelling the difficult employee’s behavior. Employee morale decreases and your organization’s resul ...
How to develop, modify and use the tools of the User/Patient Device Risk Management File per ISO 14971:2019 (a major requirement of the new QMSR), Pharma's ICH Q9, and Error Reduction with IEC 62366-1, Useability Engineering, with added HEP considerations. Ex ...
In recent years, artificial intelligence (AI) has revolutionized various industries, significantly enhancing efficiency, productivity, and decision-making processes. Within the realm of project management, AI's capabilities have opened up new possibilities for ...
This webinar will introduce you to the incredible potential of using ChatGPT to enhance your Excel tasks, focusing on practical strategies to make the most of generative AI in your daily work. We’ll start by exploring how to properly set up and structure your ...
In the tightly regulated landscape of FDA-controlled industries, successful navigation through inspections is a cornerstone of organizational success. The Most Common FDA Observations and Prevention Strategies' training addresses the critical need for professi ...
