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A Practical Introduction to Commissioning & Qualification - SOLD OUT

  • Date(s)
    Tuesday 13th and Wednesday 14th September 2016
  • Time(s)
    09.00 to 17.00
  • Venue
    National Institute for Bioprocessing Research and Training, Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland
  • Fee

    Members: €1100
    Non-Members: €1200
    NOTE: You can only book online using credit or debit card details

  • CPD Credit
    2 hours   C1

Overview

The size and importance of Ireland’s pharmaceutical industry over the past decade has been well documented. As this industry tackles the challenges of expiring patents and increasing cost pressures, new opportunities and business models are emerging in biotechnology and the convergence with related industries. However, bioprocessing facilities, processes and employee competence skills required differ significantly to those of the traditional pharmaceutical industry.

Course aim

This two-day CPD course will provide an insight into the commissioning of biopharma equipment and utilities used in biopharma plants and how they are installed, commissioned and tested. Delegates will gain a understanding of the steps involved in a commissioning program and the inputs and outputs of a successful commissioning program.

This course has been designed to equip trainees with some of the knowledge and skills required to understand and perform commissioning of plant and equipment related to the biotech industry and the content is also applicable to other industries such as oil and gas or petrochemical industries. 

This will be achieved through a combination of theoretical and hands-on practical training and will cover key competencies and key commissioning components to give the learner a grasp of the stages in the commissioning process and what happens at each stage.

Programme

Induction, Course Overview & Pre-test

​This session will act as an introduction to the course and give an overview of the different lectures and practical sessions.  It will also cover health and safety induction and general housekeeping rules in the NIBRT facility.  A pre-test and questionnaire will be given in advance of attending NIBRT to assess the knowledge of the trainees

NIBRT Utilities Lecture

This session has been designed to give a high level overview of the main areas in a modern biopharma production process. Trainees will gain an understanding of the upstream, downstream and fill finish processes of the biopharmaceutical production train.

This theory session will cover the following topics:

  • Difference between pharmaceuticals and biopharmaceuticals
  • Basic genetic engineering
  • Monoclonal antibodies
  • Overview of bioprocessing Overview of upstream processing
  • Overview of downstream processing
  • Overview of fill finish and aseptic processing

NIBRT Pilot Plant Facilities and Utilities Tour and Walk Down

This session begins with a presentation on the process at NIBRT and takes the trainee through each piece of equipment used in the production process. This will follow on with a tour through the NIBRT facility which has been purpose built to replicate a modern bioprocessing plant with state of the art equipment. This session allows the trainees insight into the production process and the requirements for successful production, including the instrumentation requirements involved. The second component of the facilities tour will comprise a tour of the NIBRT “clean utilities” plant room, during which trainees will be guided through the critical utilities systems serving the NIBRT plant.

After the initial lectures are completed the trainees will be working in a simulated GMP environment as a commissioning team, working together to commission a utility system for a biopharmaceutical production plant. The team will be put through their paces and learn in a step by step approach to get a good appreciation for the elements of commissioning listed below and how to work safely and in line with the requirements of the commissioning plan ensuring that systems and equipment are delivered on time and as required by the commissioning master plan.

Key elements of a successful commissioning program

  • Safety and Commissioning - Hazop/Risk Assessment/System definition/Documentation/Materials/Equipment
  • Commissioning Planning -  Mechanical / Structural / Electrical / Contracts / Instrumentation
  • Lock out Tag out and system boundaries - Revision Control / Punch list generation / Documentation / P&ID walk down
  • Pre Commissioning - Construction Completion / Activities / Sequencing of works
  • Commissioning - RFC, Safety, Commissioning Procedures, Commissioning test scripts
  • Start-up - Pre-start up checks, PSSR, RFSU, startup procedures
  • Initial operation - Fine tuning, Performance testing preparation
  • Performance testing - Operation, Signoff and Final Acceptance preparation
  • Post Commissioning and handover - Completion of Final Acceptance, final closeout of punch lists.

Who should attend

The course will be beneficial to any engineer or technician looking to work in the commissioning space or looking to provide engineering services to biopharma organisations and the methods are applicable to other industries also.

Download Course Profile

About NIBRT

NIBRT is a global centre of excellence for training and research in bioprocessing located in a world class facility. This practical Introduction to Commissioning & Qualification training course is a two day course designed to deliver an introduction to commissioning and qualification in the bioprocessing industry and the operations involved in a successful commissioning program. The course involves a combination of theoretical and practical sessions to introduce the trainee to the key requirements that commissioning engineers should understand to work within a commissioning team.

NIBRT has a state of the art CIP (Clean in Place) system which will be a key focus of this training for the trainee commissioning engineers. This equipment will be used to deliver an understanding of the theory and principles around commissioning practices.

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Make a Booking

13 September 2016

Terms and Conditions

Terms and Conditions

Confirmation is subject to event fee being finalised. Cancellation fees calculated at 50% of the estimated total bill will be charge for confirmed bookings cancelled less than 5 working days prior to the date of the planned event. A replacement person can attend instead. Cancellations made the day prior to an event will be charged 75% of the total estimated bill. No-shows will be charged the full fee. All cancellations must be confirmed in writing, fax or email.