This course will cover the management of “Projects” in Pharmaceutical Research. This will cover the conduct of Clinical Trials and related support activities. The course will cover the inclusion of such topics as Risk Management, Quality Management, and Regulatory Compliance as part of Project Management.
It will include the use of Quality Assurance (QA) throughout the projects.
In this two day workshop conference you will go through the common ways to do Project Management and then go through how to introduce Quality Management,, Risk Management, and Regulatory Compliance into the Project Management steps.
We will also include some suggestions on how to manage the Project Management in certain common key situations.
Upon completing this course participants should:
- Understand some approaches to managing the steps in any project
- Include Quality and Quality Management into the procedures.
- Include a risk based approach to managing the tasks, staffs, and deliverables required for the project.
- Include Compliance to applicable Regulations in your plans and execution
- To investigate true root causes of problems and to evaluate and prioritize solutions
- Problem solving methods to help you asses which is best for your situation
- Develop successful implementation plans
- Perform risk assessments effectively
Who will Benefit:
This course is designed for people tasked with managing Clinical Trials or the development of the tools used in Clinical Trials. Developing, maintaining and/or improving. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance. The following personnel will benefit from the course:
- Clinical Project Managers
- Research Physicians
- Study Monitors
- Biostatistics Managers
- Data Managers
- IT Staffs
- Financial Support professionals
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Document control specialists