Complying With FDA Requirements For Deviation Investigations2019-06-20T21:34:41+00:00

ABOUT THE TRAINING

DATE
September 10-11, 2019

LOCATION
Anaheim, CA

YOUR PARTICIPANT BENEFITS:

  1. Establish an investigation process flow that will insure consistency and thoroughness of the investigation and provide a better guidance document for remediation.
  2. 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.
  3. Reduce the amount of time required by the Investigator in conducting the search for information needed in order to compile the investigation report.
  4. Improve investigator confidence in the accuracy of the information being provided to determine the true root cause/causes of the deviation.

ORGANIZATION BENEFITS:

  1. Improve timely processing and reduction of deviation investigation back logs and insure that compliance requirements are being met.
  2. Reduction of resources required for conducting deviation investigations and reduce associated costs.
  3. 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:

  1. Track and organize data efficiently to improve the evaluation process
  2. Apply effective documentation techniques through the product life-cycle to avoid confusion and manage changes
  3. Integrate risk assessment activities into the product design process to meet expectations of “quality by design”
  4. Identify crucial training issues to address job-specific compliance responsibilities
  5. Demonstrate a proactive approach to quality and improve operational efficiency
  6. Anticipate and meet FDA expectations for a compliant quality system
  7. Incorporate risk-management strategy to quality systems application
  8. Build a quality-focused culture and facilitate management support for quality systems processes