Mettler Toledo this week announced an upcoming free webinar entitled “Ensuring USP Compliance with Revised Chapters on Weighing”.
The webinar will feature special guest presenter Gregory Martin, president of Complectors Consulting LLC.
During the free webinar, laboratory managers and professionals who are concerned with regulatory affairs, compliance and metrology can learn about the details of these latest changes, understand the impact on their weighing processes and gain advice on how to update their standard operating procedures (SOPs) to remain compliant.
The United States Pharmacopeia (USP) revisions to general chapter 41 now states that accurate weighing must be performed using a calibrated balance. Repeatability and accuracy requirements are clarified and updated, with new acceptance limits and permissible test weights.
Whereas, general chapter 1251 has been revised to focus on balance qualification and operation: including the importance of “minimum weight”.
A daily balance check, typical in the pharmaceutical industry, is not actually a requirement. Instead, the type and frequency of balance checks should be determined by the risk and process tolerance of the application.
Performing the right tests at the right intervals is designed to ensure quality results and can potentially save time and money by eliminating unnecessary testing.
General chapter 1251 also introduces “gravimetric dosing”, a state-of-the-art weighing methodology for analytical standard and sample preparation. This method involves weighing of the sample and diluent, resulting in concentration units of mg/g.
During this webinar, Gregory Martin will explain the implications of the latest USP revisions for balance users.
Weighing and compliance experts from Mettler-Toledo will advise on how SOPs should be updated to ensure compliance. This webinar will seek to provide a unique opportunity to obtain expert advice during a live question and answer session after the presentation, allowing verification that individual weighing processes are up-to-date in advance of the next audit.
The key learning objectives for webinar attendees are: to discover which tests have to be periodically performed on balances used for quantitative analysis and which acceptance criteria apply from 1st Dec, based on the USP revisions; to recognise that a daily balance check is not a requirement and get insight into the risk-based approach recommended by USP General Chapter <1251>; to learn how to assess and calculate the minimum weight of a balance and to find out more about gravimetric sample preparation and how to implement this method.
This webinar will be hosted on Dec 3, 2013 at 08:00 PST, 11:00 EST, 16:00 GMT; 17:00 CET. Event registration is at: http://tinyurl.com/webinarusp
