Industries: Pharma / BiotechMedical Device

Laboratory Equipment Validation and Qualification

Course Director: Julie Barnhill

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance) 

Course Description -

A large variety of laboratory equipment and analytical instruments, ranging from a simple apparatus to complex computerized systems, are used in the pharmaceutical industry to acquire data that will ensure that products meet their specifications.

This course will provide an in-depth understanding of how to meet FDA expectations regarding equipment validation and qualification in the analytical laboratory.  Requirement from several sources (USP, PhEur, and JP) will be referenced and the similarities and differences will discussed. It also will discuss in detail the necessary time, applicability, and activities associated with analytical instrument qualification through the whole system lifecycle – from design, installation, operation and performance qualifications to PM and removal from service.

This course is designed for those who perform, supervise, manage, audit, or oversee the validation of test methods in labs that support cGMP, GLP, and other manufacturing operations. This includes, but is not limited to, professionals in Analytical Development, Quality Control, Quality Assurance, and Validation groups. The course will also benefit those in other departments who find test method validation among their responsibilities.

Who Should Attend

This two-day course is for analysts and compliance professionals in the pharmaceutical, biopharmaceutical, and biologics industries whose responsibilities include management, supervision, and execution of laboratory equipment qualification programs.

This training will concentrate on the philosophy and understanding of the statistical principles required in conducting sound scientific investigations of laboratory processes and validation, including design and sample size issues. It will not simply present statistical formulae and the lectures are oriented toward professionals having minimal formal training in statistics or mathematics beyond basic algebra. However, for those with more formal training in statistics wishing to actually apply the techniques, appropriate time and references will be given for the procedures involved.

Course Agenda

Section 1: Introduction

  • Components of Data Quality
    • Quality Control Check Samples
    • System Suitability Test
    • Analytical Method Validation
    • Laboratory Equipment Validation and Qualification

Section 2: Laboratory Equipment Validation and Qualification Process

  • User requirements specification (URS)
  • Qualification activities
    • Design Qualification (DQ)
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ) and/or User Acceptance Testing (UAT)
  • Strategies for Validation of Computerized Lab Equipment

Section 3: Discussion of Roles and Responsibilities

  • Users
  • Quality Unit
  • Manufacturers and Suppliers

Section 4: Software Validation

  • Instrument Control
  • Data Acquisition
  • Processing Software

Section 5: Change Control

  • Changes to qualified instruments
  • Implementation of changes
  • Change Control Process
    • Assessment
    • Execution
    • Documentation
    • Approval

Section 6: Laboratory Equipment Validation and Qualification Documentation/Creation

  • Laboratory equipment validation and qualification - where to begin
  • SOP for Laboratory Equipment Validation and Qualification
  • Protocols each for IQ, OQ, PQ

Section 7: Equipment (Instrument) Categories

  • Current trends in compliance issues noted with equipment

Learning Objectives

Upon completion of this course you will have a thorough knowledge and understanding of FDA expectations regarding the validation and qualification of laboratory equipment and the know-how necessary to plan and execute effective and compliant lab equipment qualification (EQ) programs. You will also understand why laboratory equipment validation and qualification are significant as a foundational step for overall system sustainability, and why EQ is the necessary first step when initiating validation of analytical methods.

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