Pharmaceuticals 2011 - Dissolution Instrument Qualification - Webinar By ComplianceOnline

Why Should You Attend:

Qualification and calibration of analytical instruments is a key component of CGMPs in each of the major regions. Calibration failures for dissolution instruments have plagued the industry for many years. This is not unexpected, since the dissolution test is more challenging than many other analytical tests, since it involves chemical and physical factors that are changing in a very rapid timeframe. In the last several years there has been a lot of change related to qualification of dissolution instruments.

Compendial chapters on dissolution have been harmonized globally, USP introduced a new format for acceptance criteria for the Performance Verification Test, added a Toolkit to aid executing the PVT, and FDA (and others) have indicated that Enhanced Mechanical Calibration (without the use of calibrator tablets) can be an acceptable approach for qualification of these devices.

This course is designed to provide participants with an understanding of the requirements for dissolution instrument qualification and to provide strategies that will enhance success and minimize resource requirements. The course will address compendial requirements and recent FDA statements about acceptable, alternative approaches.

We will discuss the recent changes regarding the format of the USP specification for the Performance Verification Test and USP and FDA statements regarding Mechanical Calibration. Common pitfalls will be explored, and recommendations made for building a sound dissolution instrument qualification program which may reduce calibration failures as well as questions from regulatory inspectors.

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