Laboratory Equipment Validation and Qualification

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Course Director

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Course Fee

$1650.00 Regular Registration

$1450.00 Early Bird Pricing (Register 30 Days in Advance)

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Course Description

A large variety of laboratory equipment and analytical instruments, ranging from simple apparatus to complex computerized systems, are used in the pharmaceutical industry to acquire data that will ensure products meet their specifications. Yet, ensuring these tools are compliant is often a daunting challenge for even seasoned quality professionals. 



Proper equipment qualification in pharmaceutical labs is the first line of defense against data integrity issues. By attending this good manufacturing practice (GMP) equipment qualification course, attendees will ensure their laboratories produce defensible, reliable data that supports product release and regulatory submissions.

What This Course Covers

Participants of this analytical instrument validation training will learn:

Laboratory Equipment Regulation Compliance

This course will provide an in-depth understanding of how to meet U.S. Food and Drug Administration (FDA) expectations regarding laboratory equipment validation and qualification in the analytical laboratory. Requirements from several sources will be referenced, including the United States Pharmacopeia (USP), European Pharmacopoeia (PhEur) and Japanese Pharmacopoeia (JP). We also discuss the similarities and differences between them.

Comprehensive Qualification Strategies

The course discusses in detail the necessary time, applicability and activities associated with analytical instrument validation throughout the entire system life cycle, from design, installation, operation and performance qualifications to preventive maintenance and removal from service.

Participants will learn to design robust protocols that stand up to regulatory scrutiny, covering:

  • Installation qualification (IQ): You will learn to verify that equipment is installed correctly in accordance with manufacturer specifications and environmental requirements. This critical first step ensures proper utility connections, environmental controls, and documentation that form the foundation for all subsequent qualification activities.
  • Operational qualification (OQ): Participants will learn to conduct testing to ensure the equipment operates as intended within defined limits. These systematic tests verify that all instrument functions operate correctly within their specified operating ranges, providing confidence in the equipment's basic functionality.
  • Performance qualification (PQ): We will cover methods for demonstrating that the instrument performs effectively and reproducibly for its specific intended use. This final qualification phase demonstrates that the equipment consistently delivers accurate, precise results under actual operating conditions with real samples.
  • Computer system validation (CSV): Attendees will practice applying good automated manufacturing practice (GAMP) 5 principles to validate the software that controls their instruments. This specialized validation approach ensures that computerized systems meet regulatory requirements for data integrity, security and reliable electronic recordkeeping.


Who Should Attend Analytical Instrument Validation Training?

This 10-hour 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.


Professional Roles


Professionals who benefit from this training include:



  • Analytical development scientists
  • Quality control analysts
  • Quality assurance professionals
  • Validation specialists
  • Laboratory managers
  • Compliance officers
  • Method validation scientists
  • Technical services personnel


The course will also benefit those in other departments who find test method validation among their responsibilities.


Applicable Industries


This training is essential for professionals working in:

  • Pharmaceutical manufacturing companies
  • Biotechnology and biopharmaceutical organizations
  • Biologics and vaccine manufacturers
  • Contract research organizations (CROs)
  • Contract development and manufacturing organizations (CDMOs)
  • Generic drug manufacturers
  • Active pharmaceutical ingredient (API) producers
  • Medical device companies


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Additional Course Information

  • 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.

  • 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


    • Where to begin with laboratory equipment validation and qualification
    • Standard operating procedure (SOP) for laboratory equipment validation and qualification
    • Lab equipment protocols for IQ, OQ and PQ compliance

    Section 7: Equipment (Instrument) Categories

    • Current trends in compliance issues noted with equipment

  • Testimonials

    "I liked the small class size and very knowledgeable course director.  The course was much better than others I've taken."

    Sandeep S., Principal Scientist, CEM Corporation


    "The Course Director was very engaging and knowledgeable, she made it easy to ask questions and explained all the concepts in the course very well."

    Cara M., Technical Support Specialist, Avantor Sciences, UK

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.