Laboratory Compliance 2012 - Calibration and Qualification in Analytical Laboratories

This webinar will provide a detailed understanding about calibration and qualification of laboratory equipments, development of a qualification master plan, allocation of equipments to qualification categories A, B, C, and the approach for qualifying existing systems

Why Should You Attend:

Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections.

Areas Covered in the Seminar:
- Operational lab equipment requirements for calibration and qualification.
- Most common inspection problems.
- USP Chapter <1058>: Analytical Instrument Qualification.
- Development of an effective equipment qualification master plan.
- Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification.
- Allocating equipment to qualification categories A, B and C.
- Qualification and documentation requirements for each category.
- Going through the category example list.
- Approach for existing systems.
- Approach for automated systems (incl. firmware/computer systems).
- Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade).
- Documentation requirements.