Understanding the new Revision of USP 1058: Analytical Instrument Qualification

  • Speaker:Ludwig Huber
  • Date: 25th June 2018 10:00 AM PST | 01:00 PM EST
  • Duration:75Min
  • Product Code:GRC-90330

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Description:  
The first version of USP <1058> has been released in 2008. Since then it has evolved to the global standard for analytical instrument qualification. In August 2017 a new revision has been released with many new requirements mainly addressing the needs of quality systems, e.g., risk based implementation, quality agreements between service/system providers and users, and regular reviews to ensure ongoing performance. This seminar will discuss all details and give strategies and case studies for easy implementation.  

Learning Objectives: 
    - Scope and principles of the new revision.
    Changes to the previous chapter
    - Approaches for risk based qualification
   The 4Q Qualification lifecycle approach: DQ, IQ, OQ, PQ
    Purpose and contents of qualification phases: DQ, IQ, OQ, PQ
    Dealing with three instrument categories A, B and C
    The importance of quality agreements between users and suppliers
    Integrating software validation and equipment qualification
    Dealing with changes of software, firmware and equipment hardware
    Recommendations for effective implementation of the new revision

Handouts and other Materials will be shared in the meeting - 
    - For easy implementation, attendees will receive 3 SOPs
    Analytical Instrument Qualification for <1058>
    Allocating Analytical Instruments to USP <1058> categories
    Procedures and deliverable for USP <1058> categories

Target Audience:
    - Pharmaceutical and medical device industry
    Manufacturers of drug substances (APIs)
    Contract laboratories
    Everybody using analytical instruments in FDA regulated environments
    Everybody using analytical data systems in FDA regulated environments
    Analysts and supervisors
    QA managers and personnel
    Training departments
    Consultants
    Validation specialists 

Instructor: 
Ludwig Huber, Ph.D., is the director of Lab compliance and editor of Lab 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 included seminars, workshops and presentations for the US FDA, China CFDA, , ISPE, Japan PDA, PIC/S and several other national health care agencies.

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