Course Descriptor

This two-day course provides an introduction to the typical Commissioning, Qualification, and Validation (CQV) concepts and activities employed in a modern biopharmaceutical manufacturing facility. The course will include both hands-on practical and theory components, introducing topics such as CQV, Process Validation Lifecycle, Validation Risk Analysis, FAT/SAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Continuous Process Verification & Automation systems. Equipment such as stainless-steel bioreactors, utilities skids, and mobile vessels, along with Piping & Instrumentation Diagrams (P&IDs) and a tour of NIBRT’s Utilities and Pilot plant will be utilised to provide an understanding of how CQV concepts are applied to biopharmaceutical production facilities

2 Days Onsite in NIBRT

Commissioning Qualification and Validation

SKU: Commissioning-Qualification-and-Validation Category:

1,900.00

Dates:
  • 09/02/2023 - 10/02/2023

    8 Places Remaining

  • 08/06/2023 - 09/06/2023

    8 Places Remaining

  • 05/10/2023 - 06/10/2023

    8 Places Remaining

Fee:
€1900
Suitable for:

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.

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.

Key topics covered

Introduction to Commissioning, Qualification, and Validation (CQV)

NIBRT Utilities and Plant Tour

Process Validation Lifecycle

Validation Risk Analysis

FAT/SAT

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Continuous Process Verification & Automation Systems

 

Assessment

 

 

 

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