Pharmaceutical Sterilisation: Principles in Practice® (Ireland)

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Pharmaceutical Sterilisation Training: Principles in Practice® (Ireland)

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Pharma Sterilisation: Principles in Practice® – Ireland

We have produced an overview of the course information available online, available here in a handy PDF Prospectus.

Course Terms & Conditions

About the course

This is a highly practical course based on our knowledge within the industry and current projects which includes case studies and workshops to allow our delegates to put the principles into practice.

UPDATED CONTENT includes changes to Chapters 5.1.1 and 5.1.2 concerning sterilisation and biological indicators that have been significantly revised with the implementation of Revision 9.2 Ph.Eur in July2017.

According to the EU GMP Guide Annex 1, the manufacture of sterile products is subject to special requirements in order to minimise the risks of contamination, with much depending on the skill, training and attitudes of the personnel involved. In particular, managing sterilisation processes is critical to the manufacture of both terminally sterilised and aseptically prepared products.

The Pharmaceutical Sterilisation Training: Principles in Practice® training course explores sterile product manufacturing in the pharmaceutical industry and provides delegates with a comprehensive understanding of moist heat and dry heat sterilisation processes from theoretical foundation through to the practical aspects of validation and biological indicators. The course highlights the GMP requirements and current industry expectations for the routine operation, monitoring and control of sterilisation processes and gives practical examples of how these techniques are applied through appropriate engineering to ensure reliability in full compliance with all European and US regulatory requirements.

Who Should Attend This Course?

The course is designed for Engineers, Microbiologists, Technical, QA and QC personnel as well as Production and Operational personnel.

Course Features

Full course notes are provided and a certificate of attendance will be issued to each delegate who attends the full course. Certification is for knowledge gained not just attendance.

Course Objectives

Key learning objectives of the course are:

To facilitate delegates to make risk based decisions based on science through increased understanding of sterilisation technology
To improve regulatory compliance and increase awareness of industry best practice.
To Increase process capacity
To reduce re-qualification effort and ongoing costs

This course includes a combination of Presentations, Workshops, Group Activities and Demonstrations to allow you to put the Principles into Practice.