Calibration and Qualification in Analytical Laboratories

Instructor: Dr. Ludwig Huber
Product ID: 701548
  • Duration: 75 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

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:

The first version of USP <1058> has been released in 2008. Since then it has evolved as the golden global standard for analytical instrument qualification, despite of some deficiencies of the first version. For example the industry had difficulties to apply the chapter for systems comprising equipment hardware and computer systems. And there have always been comments about not enough details for the four qualification phases. These deficiencies have been clarified in the new revision with much more details on integrated systems but still some interpretation is required for compliant and efficient implementation.

This webinar will help understand the differences in the existing version. It will discuss all details and give strategies and case studies for easy implementation.


For easy implementation, attendees will receive three SOPs:

  • Allocating Analytical Instruments to USP <1058> Categories
  • Procedures and Deliverables for USP <1058> Categories
  • Analytical Instrument Qualification for <1058>

Areas Covered in the Webinar:

  • Terminology, scope and principles of the new revision
  • Changes to the existing chapter
  • Approaches for risk based qualification
  • The 4Q qualification lifecycle approach: DQ, IQ, OQ, PQ
  • Purpose and contents of equipment qualification phases: design qualification, installation qualification, operational qualification, performance qualification
  • Dealing with three instrument categories A, B and C
  • Procedures and validation deliverables for the three categories
  • Requirements for outsourcing AIQ
  • The importance of the quality agreement between users and suppliers
  • Roles and responsibilities: quality unit, manufacturer, user
  • Integrating software validation and equipment qualification
  • Integrating the USP 1058 revision with the GAMP Guide on Laboratory Computerized Systems
  • Dealing with changes of software, firmware and equipment hardware
  • Qualification of existing systems
  • Recommendations for effective implementation of the new revision
  • Expectations for the final chapter

Who Will Benefit:

  • Laboratory managers and staff
  • Analysts
  • QA managers and personnel
  • Regulatory affairs
  • Training department
  • Documentation department
  • Consultants
  • Validation specialists

Instructor Profile:

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of, 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." He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and validation around the world. This includes seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PIC/S and several other national health care agencies.

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