METTLER TOLEDO Advises How to Avoid Out-of-Specification (OOS) Results

13 Mar 2014
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 METTLER TOLEDO has announced an upcoming webinar entitled “Avoid Out-of-Specification (OOS) Results: Weighing and Sample Prep Tips", featuring guest presenter Mr. Edward Szczesny, Senior Quality Specialist at Rhodes Pharmaceuticals L.P.

In this free educational webinar, analytical and quality laboratory managers and professionals who are concerned with reducing variability and avoiding potential errors in weighing and sample preparation processes, will learn about the latest developments to tackle challenges such as: electrostatic effects on weighing; variability of manual sample preparation in a volumetric flask; and data traceability.

This webinar will be presented on March 26, 2014 at 08:00 PST, 11:00 EDT, 15:00 GMT; 16:00 CET. Click on the company website link below to register for the event. 


Out-of-specification (OOS) and aberrant results are still a big concern for analytical and quality assurance and quality control (QA/QC) laboratories in the pharmaceutical industry. Any sample that does not meet the required standards or acceptance criteria is classified as an OOS result. The US Food and Drug Administration (FDA) regulations dictate that this must be followed up thoroughly with an investigation into the cause of the result. OOS investigations have a big impact on laboratory time and resources; therefore, any error is costly.

Accurate weighing and data integrity

Analytical balances are at the heart of almost all quantitative analysis that occurs in regulated or unregulated laboratories. Accurate weighing and data integrity are essential in the preparation of analytical sample or standard solutions. Any error in these steps can have a profound impact on product quality. As half of OOS errors can be attributed to sample preparation steps or operator error, addressing these potential causes can have a significant impact on reducing OOS and aiding compliance in a regulated laboratory. Recent United States Pharmacopeia (USP) revisions to chapter <1251>, weighing on an analytical balance, describe gravimetric dosing, a state-of-the-art method for sample preparation.

Minimize user variability and OOS results

In this 60-minute webinar, experts will provide information and practical advice on how to avoid common or overlooked causes of error in weighing and sample preparation steps in order to minimize user variability and OOS results. Tips to increase weighing accuracy, minimize electrostatic effects, and produce traceable audit-proof data will be discussed. With 20 years' pharmaceutical experience in a Good Manufacturing Practices (GMP) setting, guest speaker Ed Szczesny, Senior Quality Specialist from Rhodes Pharmaceuticals, will share his insight and experience in quality assurance, as well as inventory control in a regulated environment. After the webinar, attendees should be able to: identify and address potential errors in weighing and sample preparation processes in order to address 50% of OOS and aberrant results; appreciate the impact of gravimetric sample preparation on quality of results, throughput and laboratory compliance; recognize and control electrostatic influences on weighing results; and understand the importance of electronic data handling in achieving compliance.

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METTLER TOLEDO AG
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Sarah Thomas
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