Date: Tuesday, June 22, 2010

Time: 12:00 PM (Noon) – 2:00 PM EDT

Presented by:  Thomas Baxter and James Prescott

Moderated by:  Matthew Knopp, editor of Tablets & Capsules

Description:   Pharmaceutical scientists are responsible for developing formulas and designing processes that ensure the content uniformity of tablets and capsules. Unfortunately, a number of scientists who formulate products and select and/or design processing equipment lack in-depth understanding of powder blending and segregation. As a result, processes may be developed that are not capable of providing the required blend uniformity (BU) and content uniformity (CU) of the dosage units. This can result in significant costs, production inefficiency and delays to market

This webinar will outline a methodology for identifying and addressing different categories of BU and CU (tablet) variation, including

o   Collecting and analyzing stratified BU and CU data per the FDA draft Guidance;

o   Conducting a statistical analysis of the BU and CU data, including calculating the normality of the data, overall mean and RSD, location mean values, and within-location and between-location variation via an ANOVA

o   Identifying the category that accurately describes the BU and CU variation (e.g., trending, wandering, hot spot, scatter, stray);

o   Analyzing potential next steps to further investigate the root cause(s) of the BU and CU variation for a given category of data; and

o   Reviewing potential corrective actions to reduce the BU and CU variation, including a brief overview of the basic principles of segregation and powder flow

Thomas and James will give a PowerPoint presentation and then address your questions and comments.


Webinar Cost: $99.00 USD

To Register: https://secure.netbriefings.com/event/tabletscapsules/Live/tc610/registercc.html

Source: web of tables&capsules