Communication With FDA: What Do We Say And How Do We Say It?0 Available
One must ask several questions before engaging in correspondence with FDA. When are we required to communicate with FDA? More importantly, when should we communicate with FDA? What should we say and how should we say it? What should we not say and how should we not say it? Using the case study approach, all of these questions and others will be answered in an interactive fashion
Effective Problem Solving for Life Science Professionals0 Available
This interactive session will show you how to apply a problem solving framework which will make a significant difference in how you identify causes, generate strategies, and select the best solution to your problem.
FDA Inspection Readiness – A Compliance Primer0 Available
Upon completion of the course, you will have a full and balanced understanding of the inspectional process and how to effectively prepare and participate using a strategy designed for a favorable outcome while minimizing risks. Additionally, an “Inspection Readiness Checklist” will be provided to participants as a useful job-aid.
Good Clinical Practices (GCP) Overview for Clinical Research Professionals – A Global Primer0 Available
Good Clinical Practices (GCP) are an integral part of your ability to design and execute clinical studies. The principles behind GCP provide the compliance and regulatory framework for how your trials must be conducted.