There are many factors that need to be addressed to ensure that your balances comply with the U.S. Pharmacopeia (USP) requirements when you're working under a GxP program (Good Laboratory Practices, Good Manufacturing Practices, etc.). The most important is that the selected balance is the correct instrument with the appropriate readability and repeatability to meet USP requirements for the given application and range of sample weights to be taken. This is where we must ask ourselves "Am I in compliance with USP 41? Am I in possible violation of FDA 21 CFR Part 11? Do I understand the implications of 211.68 etc?"
Schedule this half-day Pick and Mix seminar that will allow you to answer this and other key questions, and make appropriate choices for your current and future weighing applications in a regulated GxP environment.
Course Focus
- Balances and requirements for USP compliance
- Factors influencing repeatability
- Common problems and how to overcome them
- Balance location and setup
- Optimizing your weighing performance
- Provide clear guidance on the cGMP's that affect our weighing behavior and balance maintenance
- Dispel myths regarding balance compliance
- Provide clear and concise guidance on the impact of GLP on our balance selection
Course Designed For
- Anyone using or planning to use an analytical, precision, or micro balance in a regulated GxP environment;
- Those with responsibility for compliance and quality management of balances within their organization.
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