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Mettler-Toledo (MTD) Advises How To Avoid Out-Of-Specification (OOS) Results


3/7/2014 9:18:42 AM

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March 07, 2014 -- Mettler-Toledo today 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 andprofessionalswho are concerned withreducing variability and avoiding potential errors in weighing and sample preparation processes, will learn aboutthe latest developments to tackle challenges such as: electrostatic effects on weighing; variability of manual sample preparation in a volumetric flask; and data traceability.

Press Release: Mettler-ToledoAdvises How to Avoid Out-of-Specification (OOS) Results
This webinar will be presentedon March 26, 2014 at 08:00 PST, 11:00 EDT, 15:00 GMT; 16:00 CET. Event registration is at: http://tinyurl.com/ooswebinar

Out-of-specification (OOS) and aberrant results are still a bigconcern for analytical and quality assurance and quality control QA/QC laboratories in the pharmaceuticalindustry. 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, anyerroriscostly.

Analytical balances are at the heart of almost all quantitative analysisthatoccurs in regulated or unregulatedlaboratories. Accurateweighing and data integrity are essential in the preparation of analyticalsample or standard solutions. Anyerror in thesestepscan have aprofound impact on product quality. As half of OOS errorscanbeattributed to samplepreparationsteps or operatorerror, addressing these potential causes can have a significant impact on reducing OOS and aiding compliance in a regulated laboratory. RecentUnited States Pharmacopeia (USP)revisions to chapter<1251>, weighing on an analytical balance, describegravimetricdosing, a state-of-the-art method for samplepreparation.

In this 60-minutewebinar, experts willprovide information and practicaladvice on how to avoidcommon or overlooked causes of error in weighing and samplepreparationsteps in order to minimize user variability and OOS results. Tips to increaseweighingaccuracy, minimizeelectrostaticeffects, and producetraceable audit-proof data willbediscussed. With 20 years' pharmaceuticalexperience in a Good Manufacturing Practices(GMP) setting, guest speaker Ed Szczesny, Senior Quality SpecialistfromRhodes

Pharmaceuticals, willsharehis insight and experience in quality assurance, as well as inventory control in a regulatedenvironment.

After the webinar, attendeesshould be able to: identify and addresspotentialerrors in weighing and samplepreparationprocesses in order to address 50% of OOS and aberrant results; appreciate the impact of gravimetricsamplepreparation on quality of results, throughput and laboratorycompliance; recognize and control electrostatic influences on weighingresults; and understand the importance of electronic data handling in achievingcompliance.

This webinarwill be presentedon March 26, 2014 at 08:00 PDT, 11:00 EDT, 15:00 GMT; 16:00 CET. Event registration is at:http://tinyurl.com/ooswebinar

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