3-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries

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.

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.

Areas Covered in the Session :

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

Who Should Attend:

  • 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

FDB2989

Joy McElroy

Joy McElroy offers 14 years of experience as a consultant and over 20 years’ total experience in the pharmaceutical and biotech industries in quality control, clinical settings, good manufacturing practice (GMP) auditing as well as validation engineering. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, GMP and good laboratory practice training. She has written and executed equipment qualification and validation protocols for numerous companies. Joy is co-owner of Maynard Consulting Company.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.