Investigating Microbial Data Deviations

North Bethesda, MD
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

Out of Specification (OOS) test results are sometimes encountered during analytical testing of drug substances and products. Existing FDA guidance addresses the investigation of OOS test results, but is silent on the subject of data deviations encountered in microbiological testing. However, these are often encountered in pharmaceutical quality control laboratories. This course will provide a practical approach which may be applied globally for the investigation of microbiological data deviations. The roles of manufacturing, the testing laboratory and Quality Assurance will be considered, and fundamental elements to be addressed in writing reports summarizing those investigations will be covered. Flowcharts, checklists and process flow diagrams will be utilized to illustrate the concepts presented. This course is based on an upcoming PDA Technical Report addressing the same subject.

This course will provide practical insights into both the regulatory and scientific elements which must be taken into consideration when investigating microbiological data deviations. Participants will come away with an understanding not only of what the considerations are, but a practical approach of how to design and conduct investigations into microbiological test data which appears inconsistent with expectations and trends.

Who Should Attend

This course will be of value to quality control staff who conduct and assess the results of microbiological testing. It will also be of benefit for those quality control and quality assurance staff who conduct investigations into microbiological data deviations and write and approve reports of those investigations. Analysts, laboratory supervisors and managers and quality assurance staff will all benefit from attendance at this course.

More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Identify microbiological test results which deviate from anticipated results and trends
  • Explain the responsibilities of laboratory, manufacturing and quality assurance staff in preparing for, conducting, reviewing and documenting investigations into microbiological data deviations
  • Describe the essential elements of reports of investigations into microbiological data deviations
  • Discuss the benefits of flowcharts, checklists and process flow diagrams as they apply to the investigation process
  • Apply the concepts learned in situations involving microbiological data deviations when necessary
Agenda is subject to change.

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Bethesda North Marriott Hotel & Conference Center

5701 Marinelli Rd
North Bethesda, MD , United States

Jeanne Moldenhauer, Excellent Pharma Consulting