Calibration and Qualification in Analytical Laboratories

Dr. Ludwig Huber
Instructor:
Dr. Ludwig Huber
Duration:
75 Minutes
Product Id:
500398
Access:
6 months

More Trainings by this Expert

Price Details
$183 Recorded
Price Detail Options
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
  • 20+ Examples for Instrument OQ Testing

Areas Covered in the Session:
  • 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


Speaker Profile
Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website www.ludwig-huber.com




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