The Role of Logbooks and Recordkeeping in Identifying Root Causes virtual, sheridan

OVERVIEW
An out-of-compliance under GLP or ISO 17025 is a discreet and specific event. Its occurrence has major consequences for the laboratory operation. Can the incident and its timing give clues to what caused the non-compliance?

The records in a lab – the logbooks for chemicals, reagent and calibration solutions, sample preparation, instrument maintenance and calibration, for quality checks – all are time-oriented. This gives a window of cause-and-effect or coincidence that can give clues. The sum of these, plus the symptoms of the non-compliance can point out the likely root cause.

WHY SHOULD YOU ATTEND?
Tracking down the cause of non-compliance can be a time-consuming and difficult task. However, in a compliant laboratory, there are numerous records covering everything done within the laboratory. These records are a coordinated and interlocking system that can be a key tool in finding certain root causes. Using both scientific and operational clues can help pinpoint the root causes in a faster and more valid way. This webinar will describe the approach and some examples of how to do this.

LEARNING OBJECTIVES
Proper laboratory information is rich in facts that aid in identifying the root causes of a problem (non-compliance event). Date and times can be matched to the event/ Changes in operation, such as a repair or maintenance of an instrument or using a different lot number of a solvent can give an idea of what symptoms match those seen. Some examples will be given, as well as how to use other expected symptoms to corroborate the root cause.

AREAS COVERED
Major topics covered:

What records are there in a compliant laboratory?
Non-Compliance
Symptoms — What is normal?
How is this abnormal?
What are possible causes?
How are these tracked by the records?

About speaker
Dr. Fetzer has had many roles in compliance under Good Laboratory Practices and ISO 17025. He developed liquid chromatography and physical-property assays for a variety of compounds. He supervised a compliant laboratory for over a decade. He has performed outside audits for “mock” compliance audits. He has been training in this topical area for many years.

Dr. Fetzer’s expertise extends beyond academia, having published over 100 peer-reviewed scientific articles, 2 books, and 8 book chapters. He was key in overseeing the Good Laboratory Practices accreditation for a prominent research chromatography laboratory. Additionally, Dr. Fetzer has shared his knowledge by conducting numerous short courses on GLP and ISO 17025 compliance.

Beyond his contributions to the scientific community, Dr. Fetzer offers Analytical Chemistry Consulting Services and Scientific Career Development Consulting services. As an American Chemical Society tour speaker, he has delivered over twenty invited lectures at conferences, universities, and government laboratories, further solidifying his impact in the field.