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Understanding and Implementing USP <1058>: Analytical Instrument Qualification

 
  January 14, 2011  
     
 


ComplianceOnline, Online Event
2011-03-22


NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.  

Why Should You Attend:

Analytical instruments should be qualified to demonstrate suitability for the intended use. Companies are unsure on what exactly to qualify or re-qualify, test and document.  The main reason is that unlike for analytical methods there was no clear standard with details for equipment qualification. This has changed. The USP has developed a chapter that provides a framework for analytical instrument qualification (AIQ).

This USP <1058> webinar will give a good understanding of current and future FDA requirements  and the USP framework. It also will provide detailed steps, examples and tools for cost-effective implementation.

Areas Covered in the Seminar:

  • FDA and EU requirements for analytical instrument qualification.
  • Most common inspection problems.
  • Terminology, scope and principles of the new USP chapter.
  • AIQ and its relation to method validation, system suitability testing and quality control checks.
  • Essential steps for AIQ: DQ, IQ, OQ, PQ
  • Purpose and contents of equipment qualification phases: design qualification, installation qualification, operational qualification, performance qualification.
  • Recommendations for firmware and software validation.
  • Roles and responsibilities: QA, manufacturer, user.
  • Approach for automated systems (incl. firmware/computer systems).
  • Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade).

Free Hand-outs : For easy implementation, attendees will receive

  • Copies of all slides
  • SOP: Analytical Instrument Qualification
  • SOP: Allocating Analytical Instrument to USP <1058> Categories
  • SOP: Procedures and Deliverables for Qualification of USP <1058> Instrument Categories

Who Will Benefit:

  • (Bio)Pharmaceutical Companies
  • Manufacturers of drug substances (APIs)
  • Contract laboratories
  • Everybody involved in analytical instrument qualification
  • Laboratory Managers
  • QA managers and personnel
  • Analysts
  • Metrology groups
  • Validation specialists
  • Suppliers of analytical equipment
  • Regulatory affairs
  • Training department
  • Consultants
  •  
     
    Organized by: ComplianceOnline
    Invited Speakers: Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor of www.labcompliance.com , the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber's website: www.ludwig-huber.com .
     
    Deadline for Abstracts: 2011-03-22
     
    Registration:

    Attend Live Online Training

    $295.00 One Dial-in One Attendee

    $1,145.00 Group–Max. 10 Attendees 

     

    E-mail: admin@complianceonline.com
     
       
     
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