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Calibration and Qualification in Analytical Laboratories - Webinar

  • ID: 4061809
  • Webinar
  • March 2017
  • Region: Global
  • 75 Minutes
  • NetZealous LLC
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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 Categories
20+ Examples for Instrument OQ Testing

Areas Covered in the Session:

Lab equipment requirements for calibration and qualification
Most common inspection problems
USP Chapter : 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
Note: Product cover images may vary from those shown
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  • QA managers and personnel
  • Analysts and lab managers
  • Analysts
  • QA managers and personnel
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants
Note: Product cover images may vary from those shown
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  • Ludwig Huber Dr Ludwig Huber,
    Director and Chief Editor ,
    LabCompliance


    Dr. Ludwig Huber is Director and Chief Editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories . Mr. Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion member at US-FDA industry training sessions and conferences.

    He served as a team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on laboratory equipment. In addition, he was awarded as Presenter of the Year of the Institute for Validation and Technology. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press.

Note: Product cover images may vary from those shown
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  • QA managers and personnel
  • Analysts and lab managers
  • Analysts
  • QA managers and personnel
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants
Note: Product cover images may vary from those shown
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