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Understanding and Implementing USP 1058 - Analytical Instrument Qualification - Webinar

  • ID: 4013482
  • Webinar
  • July 2017
  • Region: Global
  • 90 Minutes
  • Online Compliance Panel
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This webinar is designed to provide both a regulatory compliant and practical overview of equipment/instrument qualification, including requirements associated with instrumental system validation. This is critical in meeting existing regulatory requirements and ensuring efficient and cost-saving quality measurements and operations. In addition to USP < 1058>, this will review other related compliance requirements, along with a practical overview of establishing an effective and efficient equipment qualification process. This will present details from an overall process, each of the individual components, documentation, training, to implementation.

Objectives of the Presentation:
  • Understand regulatory requirements for equipment qualification / system validation
  • Understand equipment classification per appropriate usage and risk requirements
  • Differentiate between calibration, DQ, IQ, OQ, PQ, system validation and the related requirements
  • Understand appropriate data archival system requirements - electronic, hardcopy, hybrid
  • Understand qualification processes and responsibilities - plan, implementation, life-cycle
  • Understand required compliance documentation (plans, SOPs, protocols, reports, equipment, training)
  • Understand GLP usage requirements for qualified / calibrated versus unqualified equipment
Why Should you Attend?

The risk associated with equipment qualification non-compliance can range from a minor consequence, product failure, recall, an FDA 483, or even worse. It is not only important to understand and have an appropriate equipment qualification plan in operation for regulatory compliance, but also for good science, to ensure quality, and to support good business practice.

This webinar is designed to provide an efficient overview, along with supporting details, practices, and examples to create and implement an appropriately suitable equipment qualification program.

Areas Covered:
  • The validation plan and compliance requirements - what, why, who, when, where
  • Discuss appropriate equipment classification assignment and failure mode and effect analysis
  • Differentiate between calibration, qualification and validation
  • Calibration, DQ, IQ, OQ, PQ, PT, system suitability and system validation requirements
  • The qualification process and responsibilities
  • Supporting data, documentation and record storage
  • Implementation, practice, preventative maintenance, requalification / validation
Topic Background

Equipment/instrument qualification is an internationally described regulatory requirement necessary to ensure good scientific measurements, maintain product quality and safety and to optimize efficient and reliable business practice.
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  • Larry Stevens Larry Stevens,


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Intended for the pharmaceutical Industry:
  • QC Managers, Supervisors and Analysts
  • QA Managers and Personnel
  • Regulatory and Compliance Professionals
  • R&D Managers, Supervisors and Analysts
  • IT/IS Managers and System Administrators
  • Metrology
  • Validation Specialists
  • Training departments
  • Consultants
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