Calibration and Qualification in Analytical Laboratories 2015

Topics

• Most common inspection problems
• Lab equipment requirements for calibration and qualification
• Development of an effective equipment qualification master plan
• USP Chapter [1058]: Analytical Instrument Qualification
• Allocating equipment to qualification categories A, B and C
• Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
• Going through the category example list
• Qualification and documentation requirements for each category
• Approach for automated systems (incl. firmware/computer systems)
• Approach for existing systems
• Documentation requirements
• Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
• Update on the new revision of USP [1058]

Who should Attend

Professionals from Pharmaceutical companies, API manufacturers, Clinical testing laboratories and Contract manufacturers and laboratories, including:

• Analysts and Lab Managers
• QA Managers and Personnel
• Regulatory Affairs
• QA Managers and Personnel
• Documentation Departments
• Training Departments
• Consultants