Understanding and Implementing USP 1058 - Analytical Instrument Qualification

Duration: 90 Minutes
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.
USP 1058
Instructor: Larry Stevens
Product ID: 501960
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 an 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
Who will Benefit
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
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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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Larry Stevens is a pharmaceutical science consultant focusing on strategic product development, quality and regulatory compliance. This encompasses quality by design, gap and risk analysis, experimental analytics, and the development and validation of methods, processes and environments.

He has extensive experience working for both large and small pharma companies and successfully working with a wide range of product types. Product development accomplishments include the strategic design of controlled release suspensions and the first orally disintegrating tablet on the market. Other accomplishments include the development and validation of hundreds of analytical methods, along with instrument, software, process and cleaning validations, SOPs, and successful CMC submissions.

The author of numerous articles, an internationally recognized speaker and conference chair, and a recipient of the Alcon Laboratories research award, Larry now consults in strategic quality product and analytical development, successfully meeting needed regulatory compliance requirements.
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