Minimizing Out-of-Specification (OOS) Errors Using a Risk-Based Gravimetric Approach - METTLER TOLEDO
Webinar - On Demand

Minimizing Out-of-Specification (OOS) Errors Using a Risk-Based Gravimetric Approach

Webinar - On Demand
Out-of-specification (OOS) errors are a major concern within analytical and QA/QC laboratories in the pharmaceutical industry because of the impact of investigations on time and resources. Fifty percent of OOS errors can be attributed to either sample preparation steps or operator error. Confidence in analytical results begins with accurate weighing because errors in the first step will have a knock-on effect.
1 hr
English

Determining the risk within a process, respecting the minimum weight, and applying the appropriate safety factor during the weighing step can address most of the weighing errors. Error-prone manual steps, undertaken during preparation of a specific concentration of solution, especially those involving volumetric glassware, can easily be replaced by the more accurate gravimetric equivalent. In addition, automation has the potential to eliminate user variability.  

This 60-minute webcast will explain how to use an automated gravimetric approach to improve sample-preparation workflows by offering insight from leading industry experts, including Dr. Charles Ray, former Associate Director of Analytical R&D at Bristol-Myers Squibb, who will share his practical experience in managing analytical workflows.

 

Key Learning Objectives:

  1. Learn how to identify and address the potential errors in manual weighing and sample- preparation steps to avoid out-of-specification (OOS) results
  2. Understand how to use a risk-based approach to have confidence in your weighing results
  3. Discover how automated gravimetric methods reduce the variability and number of steps in the sample preparation process as well as provide substance savings

 

This would be of interest to:

  • QA/QC Managers, Directors, and Department Heads
  • Analytical Laboratory Managers, Directors, and Department Heads
  • Compliance Managers, Regulatory Affairs Managers, and Global Metrology Managers
  • GMP and CMC Consultants, GLP Auditors, and Quality Consultants
  • Laboratory Managers, Laboratory Supervisors, and Production Managers

 

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