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6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices) - Webinar

  • ID: 4833644
  • Webinar
  • September 2019
  • Region: Global
  • 6 Hours
  • NetZealous LLC
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This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.

Why you should attend

This is an area of growing concern, sometimes ridden with uncertainty as to what needs to be done at each of stages of the Product Lifecycle. In modern Pharmaceutical and Biotech laboratories, a composite array of various gadgets, devices, analytical instruments and computerized systems are used daily.

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Session 1

  • Introduction
  • Quality Systems, Paradigm Shift, Global Perspectives
  • QA/QC Validation
  • Risk Assessment

Session 2

  • Measurement, Resolution, Errors, and Uncertainty
  • Regulatory and QS Requirements
  • The Product Life Cycle Concept
  • USP chapter 1058
  • Examples of Various Systems

Session 3

  • Strategies for Validation
  • Documentation /Master Validation Plan

Session 4

  • Training Requirements
  • Examples of Various Systems
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  • Joy McElroy Joy McElroy,
    Principle Consultant ,
    Maynard Consulting Company


    Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.

    Now with 12 years experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.

    Joy specializes in Equipment Qualification, Cleaning Validation,Sterilization, Environmental Monitoring, and GMP Compliance Auditing.

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  • Scientists
  • Managers
  • R&D Personnel
  • Quality Assurance / Quality Control Staff
  • Validation Managers
  • Validation Coordinators
  • Production and Process Development Personnel
  • Regulatory/Compliance Managers
  • Chemists
  • Technicians Study Directors(GLP)
  • Qualified Persons (EMEA)
  • Pharmaceutical Development
  • CRO Staff
  • CRO Managers, Accredited Laboratories in general
  • Any one engaged with Test Methods
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