Continuing Education credits are not available for the archived offering.
This archived webinar is available for purchase through April 30, 2015.
Duration: 1 hour 21 minutes
Essential information and practical skills are needed to build a strong foundation for identifying and managing risks to quality in the protocol development process. Quality by Design (QbD) emphasizes building quality into the process from the beginning to help avoid risks from becoming realized. The Critical to Quality (CTQ) parameters also need to be identified. This webinar will outline what aspects of a trial have a meaningful impact on patient safety and interpretation of trial results, including:
- What proactive steps can be taken to avoid risks/problems inherent in running a clinical study
- Identification of critical to quality factors in protocol design
- What ongoing checks can be performed to detect problems
- How will the impact of any corrective actions be assessed
Who should attend?
Professionals involved in:
- Clinical Development
- Clinical Operations
- Medical Monitoring
- Medical Writing
- Regulatory Affairs
- Quality Assurance
- Quality Management
- Risk Management in support of Clinical and Device Trials
At the conclusion of this webinar, participants should be able to:
- Discuss the regulatory expectations for applying Protocol Quality by Design
- Describe the concepts of Quality by Design (QbD) including protocol design, trial operations, monitoring, and quality improvement
- Define “errors that matter” in other words the Critical to Quality (CTQ) parameters in clinical trial design and execution
- Determine priorities for addressing CTQ parameters
- Discuss how Quality by Design can be implemented within your organization
Ways to register
- Individual registration is a license for ONE internet login allowing one viewer.
- Group site registration is a license for ONE internet login allowing multiple viewers from one location.
- Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.
Cancellations: No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs