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Validity : 13th Apr'24 to 23rd Apr'24
How to deal with bad results under GLP
- The non=compliance event
- Review of documents and control charts
- Synchronization of the event to laboratory operations
- Blunders
- Outliers and outlier testing
Overview of the webinar
Assessment of the cause for non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.
In the case of an apparently normal; our data point, assessment of whether it really is an outlier using statistics are done. If so, an assessment of an observable cause is done to find the blunder. If one is not found, the process for handling outliers is followed.
Who should attend?
This webinar will provide valuable assistance to the following personnel from regulated laboratories in the pharmaceuticals, chemicals, and petrochemicals industry:
- Analysts
- Lab Supervisors and Managers
- QA managers and personnel
- Consultants
- Validation Specialists
- Chemists
Why should you attend?
There are many causes for a bad result. The main symptom is a result outside is +/- 3σ. This is a GLP non-compliance event. A root-cause / failure analysis must be done. What are the steps? There are both immediate in-laboratory and outside-of-laboratory steps.
When there is a non-compliant result, immediate steps involve both the laboratory personnel and management. Internally, a review of the specific conditions for the bad result must be assessed. This includes checking control charts to see if trends in performance occurred. All logbooks and recordkeeping related to that analysis must be examined carefully. An initial report to the lab manager is made. Meanwhile, all regular operations of that method must stop and customers must be informed. Root-cause teams are set up to assess the preliminary assessment as well as control charts and other operational data to see if a cause is clearly shown. The timing of the non-compliance is compared to these records.
The closure is done by issuing a root-cause report with corrective actions. Revalidation is done. Customers are informed.
There are also several types of situations for a laboratory operating under Good Laboratory Practices (GLP) were assessing whether results are acceptable and must be used or unacceptable and can be ignored. Results with blunders, the possibility of outliers, and other questionable results can be tricky and a source of serious non-compliance events. Blunders are the easiest type of bad result. Documenting blunders must be done thoroughly, though. Outliers are more problematic but can be clearly dealt with. Outlier testing is crucial.
Faculty - Dr.John Fetzer
Dr. John C. Fetzer, PhD offers over 20 years of expertise in Analytical Chemistry, focusing on Polycyclic Aromatic Hydrocarbons, Petroleum and its Products, Chromatography, and UV and Fluorescence Spectroscopy. He offers Analytical Chemistry Consulting Services and Scientific Career Development Consulting services to companies, organizations, and individuals. Dr. Fetzer has over a decade of experience as a supervisor, team leader, trainer, and coach. He has published over 100 peer-reviewed scientific publications, 2 books, and 8 book chapters.
Dr. Fetzer is an American Chemical Society tour speaker, who has participated in over twenty invited lectures at conferences, universities, and government laboratories.