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  • Thorough and Complete Investigations and Follow-up - A
    Current Regulatory Expectation

  • Hosted By:
  • omplianceOnline
  • Start:
  • Thursday - Oct 31, 2013 10:00 AM
  • End Time:
  • Thursday - Oct 31, 2013 11:30 AM
  • Location:
  • Online
  • This training will address the adequate investigation of deviations, an area that is receiving FDA attention as evidenced by citations in Warning Letters and 483 observations. Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future.

    Why Should You Attend :
    Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that include the root cause of deviations. FDA 483 and Warning letter observations identify inadequate investigations and follow-up.
    The timely investigation of deviations with appropriate corrective and preventive action is clearly a US FDA expectation. The international regulatory expectation for a structured approach to investigations that lead to corrective actions and preventive actions is clearly stated in ICH Q10, Pharmaceutical Quality System, and supported in the FDA Guidance to the Industry, Quality System Approach to Pharmaceutical CGMP Regulations. FDA Inspectional observations in inadequate constitute the largest number of observations during the most recent two years.
    This course will include a discussion of the Deviation System, the relationship with investigations and the CAPA system, what should be investigated and the level of investigation. Several tools that will lead to the identification of the root cause will be discussed. These include: process mapping, brainstorming, cause analysis, cause and effect and the 5 Whys. The investigation system will be integrated with the CAPA and Change Control Systems.

    Areas Covered in the Seminar:
    -What should be investigated - Complaints, audit observations, deviations, discrepancies, calibration out-of-tolerances
    -FDA expectations for investigations and observations
    -The investigation/problem resolution process - understand the problem, identify possible causes, data collection, data analysis, root cause identification, root cause elimination, solution implementation, verify success
    -Tools for understanding the process - mapping, critical incident, performance matrix
    -Tools for understanding the possible causes - brainstorming, is/is not, nominal group
    -Tools for narrowing the investigation to the cause - data collection, data analysis
    -Tools for determining the root cause cause and effect, Fault tree, 5 Whys
    Corrective action
    Preventive Action

    Who Will Benefit:
    -QA document reviewers
    -QA personnel responsible for reviewing investigations reports
    -QA personnel responsible for the deviation and investigations systems
    -Quality and Operations personnel responsible for investigations
    -Personnel from all units responsible for initiating investigations
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