2012 - FDA Compliant SFC Qualification and Performance Testing

This seminar will present strategies for suppliers to maximize business and for users to minimize validation cost.

Why to attend:

The Application of Supercritical Fluid Chromatography (SFC) in Pharmaceutical and Biopharmaceutical industry is expanding from research to development and to quality control in manufacturing. The reason is that new instruments have been developed that provide the performance, reliability and robustness that are required by various regulations and guidelines. This means that now SFC equipment should be qualified. Because there is no or little experience with SFC qualification the industry has many questions. This seminar provides information and tools for SFC qaulification and testing.

Areas Covered in the Seminar:

* FDA and equivalent international requirements
* Examples for recent 483s and Warning Letters for equipment qualification
* SFC instrument qualification according to USP <1058>
* Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
* Selecting parameters and acceptance limits for SFC initial and on-going testing
* Recommended test sequence for highest efficiency
* Approach for existing systems
* Approach for automated systems (incl. firmware/computer systems)
* Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
* Documentation requirements?

Date: January 12, 2012
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide (oder USA, nicht Germany, fall das möglich ist)

Who should attend
* Laboratory managers and staff
* Analysts
* QA managers and personnel
* Regulatory affairs
* Training departments
* Documentation department
* Consultants

Weblink: http://www.labcompliance.com/seminars/audio/282/de...

Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, FDA, validation