ABOUT THE TRAINING
September 10-11, 2019
YOUR PARTICIPANT BENEFITS:
- Establish an investigation process flow that will insure consistency and thoroughness of the investigation and provide a better guidance document for remediation.
- Provide a better understanding of how the components of the investigation work in conjunction with each other and the value that they provide. Such as: Root Cause Analysis, Corrective and Preventive Action, Interviews, Risk and Impact Assessments, Change Controls and Results Assessments.
- Reduce the amount of time required by the Investigator in conducting the search for information needed in order to compile the investigation report.
- Improve investigator confidence in the accuracy of the information being provided to determine the true root cause/causes of the deviation.
- Improve timely processing and reduction of deviation investigation back logs and insure that compliance requirements are being met.
- Reduction of resources required for conducting deviation investigations and reduce associated costs.
- Insure that product safety requirements are consistently being met and that identified deviations are not repeated.Reduce the potential of violations associated with product/process deviations that might be identified during agency inspections.
AFTER THIS TRAINING COURSE,
YOU WILL BE ABLE TO:
- Track and organize data efficiently to improve the evaluation process
- Apply effective documentation techniques through the product life-cycle to avoid confusion and manage changes
- Integrate risk assessment activities into the product design process to meet expectations of “quality by design”
- Identify crucial training issues to address job-specific compliance responsibilities
- Demonstrate a proactive approach to quality and improve operational efficiency
- Anticipate and meet FDA expectations for a compliant quality system
- Incorporate risk-management strategy to quality systems application
- Build a quality-focused culture and facilitate management support for quality systems processes