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. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. 

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.

Who Will Benefit:

The following personnel from pharmaceutical development and quality control laboratories, food, environmental, clinical and chemical testing laboratories and contract laboratories will benefit:

• QA managers and personnel
• Analysts and lab managers
• Analysts
• Regulatory affairs
• Training departments
• Documentation department
• Consultants