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Pharmaceutical Sterilisation: Principles in Practice - Ireland

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Pharmaceutical Sterilisation Training: Principles in Practice® - Ireland

Download Course PDF: Sterilisation Training Principles-in-Practice®

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® course 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.

Course Content

• Development of Current Sterilisation standards
• Principles of Moist Heat Sterilisation
• Steam Quality Generation Distribution and use
• Dry Heat Sterilisation and Depyrogenation
• Instrumentation and Control of Sterilisation Processes
• Steam In Place
• Quality Systems Associated with Sterilisation Processes
• Auditing Sterilisation Processes and Preparing for a Regulatory Inspection
• Biological Indicators
• Validation Strategies for Sterilisation Processes
• Routine Operation of Sterilisers
• Continual Compliance Assurance

Course Dates / Costs Description

Note: Our online booking system works in € Euro for Courses in Ireland.

Honeyman reserves the right to amend any prices at any time. All advertised prices are exclusive of any applicable VAT or local taxes.

Course Terms & Conditions

Click here to read our Course Terms & Conditions.

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Why Honeyman?

The Honeyman Group has trained thousands of people within the pharmaceutical industry. Our courses continue to remain popular because they provide delegates with a sound understanding of scientific principles in each technical area, complemented by interactive workshops, discussions, practical demonstrations and case studies to put these principles into practice.

All of our courses are delivered by experts who actively work within the pharmaceutical, biopharmaceutical and medical device industries, therefore, we will continue to share pragmatic current best practice advice to enable you to meet current GMP and regulatory expectations.

• Our speakers are active in the industry today and are able to provide up to the minute experiences and current best practice advice
• We can provide bespoke on site training, perfectly suited to deliver the most effective and relevant training

Read training testimonials from previous delegates and commissioning organisations.