QA and Risk Management approaches when managing clinical trials online course Instructor Michael discusses applying risk-based decision making to ensure the long-term impacts of your company’s current decisions are fully understood. He covers:
Conducting Clinical Research is a complex process and involves balancing Costs, Time, and Risks to ensure that the drug(s) under investigation can be proven to be safe and effective, and that the relevant Regulatory Authorities are provided with the data to confirm this.
Managing Risks in all aspects of the data collection process is a key to meeting the aforementioned objective, and with the changing landscape of the Clinical Trial environment, each QA function should play a key role in Risk Management activities, working with the relevant Clinical Development teams and providing input, as and when needed.
This presentation focuses on the role of QA in the Risk Management process when deciding on how data should be collected and ensuring the sources of the data are acceptable quality to meet the required company and regulatory standards.
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Outline the role of QA in Risk Management
Risk Management methods and tools
Methods used to measure the overall quality of Clinical Trial data
Identify and manage risks of clinical trials
Ways to integrate quality risk management (QRM) into your quality systems, such as change control and investigations, and how integration can benefit your organization;
- Risk management tools available to you to meet regulatory requirements
Recognizing the critical QRM regulations that apply to Pharma.
Who Will Benefit
- QA/QC Personnel
- R&D Management
- Compliance Officers
- Executive Management
- Laboratory Management
- Risk Management Specialists
- Regulatory/legislative Professionals
- Manufacturing Directors and Supervisors
- Validation Specialists, Scientists