Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel 2011

  • 19 Apr 2011
  • Webinar

Description

Overview: 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. Companies are unsure on what exactly to qualify test and document.

For easy implementation, attendees will receive:
  • 4 SOPs
    • User Requirement Specifications (URS) for analytical equipment
    • Change control for analytical equipment
    • Qualification of equipment
    • Allocating Analytical Instruments to USP <1058> Categories

  • Allocating Analytical Instruments to USP <1058> Categories

Areas Covered in the Session:
  • 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:
  • QA managers and personnel
  • Analysts and lab managers
  • Analysts
  • QA managers and personnel
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultans

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Important

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Event Categories

Health & Medicine: Hospitals & Clinics, Medical device, Medical laboratories
Science: Laboratories

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