Introduction to Commissioning, Qualification, and Validation

Overview

This comprehensive 2-day course provides an introduction to the typical Commissioning, Qualification, and Validation (CQV) concepts and activities employed in a modern biopharmaceutical manufacturing facility.

This course delivers theory covering CQV, Process Validation Lifecycle, and Validation Risk Analysis. The hands-on practical sessions compliment this theory with topics covering Commissioning, FAT/SAT, Installation Qualification (IQ), Operation Qualification (OQ), and Continuous Process Verification (CPV) at an introductory level.

Key topics covered

  • An introduction to the concepts and typical terminology associated with modern CQV.
  • An overview of the stages in the Process Validation Lifecycle and a look at the importance of Risk Analysis and Risk Management in CQV.
  • An introduction to early-stage CQV activities, such as User Requirement Specification (URS), safety activities, equipment calibration, and alarm and interlock checks using a stainless-steel bioreactor.
  • An introduction to equipment walkdowns using General Arrangement (GA) drawings and Piping & Instrumentation Diagrams (P&ID), equipment and automation operational testing, and process monitoring and trend analysis.

Who should attend

This course is designed for operators, technical staff, engineers, managers, and graduates wishing to gain an introductory knowledge of Commissioning, Qualification, and Validation activities in the Biopharmaceutical Industry.

What do Attendees Obtain on Completion?

An MCQ quiz will be taken at the end of the course. Attendees will receive results and a certificate of completion.

Register

Introduction to Commissioning, Qualification, and Validation

€1,990.00

8 - Introduction to Commissioning Qualification and Validation

Course Format

Onsite Training at NIBRT

Onsite Training at NIBRT

  • 2 full days onsite training at NIBRT facility

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Dates & Price

Dates:
  • Course 1
    10/02/2025

    NIBRT- Onsite course

    €1,990.00

    7 Places Remaining

  • Course 2
    29/05/2025 - 30/05/2025

    NIBRT- Onsite course

    €1,990.00

    8 Places Remaining

  • Course 3
    15/09/2025 - 16/09/2025

    NIBRT- Onsite course

    €1,990.00

    8 Places Remaining

  • Course 4
    01/12/2025 - 02/12/2025

    NIBRT- Onsite course

    €1,990.00

    8 Places Remaining

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