Sterilisation: Principles in Practice
September 2008
Intensive 3-day course

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Introduction
According to the EU GMP Guide Annex 1, the manufacture of sterile products is subject to special requirements in order to minimise 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.

This course provides both a theoretical foundation and a practical application of sterilisation equipment. Detailed guidance on current requirements for qualifying steriliser equipment and validating sterilisation processes is included in the scope of the programme. In addition, the GMP expectations for the routine operation, monitoring and control of sterilisation processes is also provided.

The course is compiled by industry professionals who have extensive experience in the pharmaceutical and medical devices industries, and is designed to present an independent view of sterilisation techniques and processes. The course has run for many years worldwide and is regularly updated, based upon the experience of the tutors, and represents current best industry practices.

Course Tutors
Mark Thompson B.Sc. (Hons), C. Eng. M.I.E.E. Managing Director, Honeyman Group Ltd

Mark's engineering background in the pharmaceutical and medical device industries includes Eli Lilly, Rhone Poulenc Rorer and Smith and Nephew Medical Ltd. Specialising in sterilisation technology, engineering and microbiology, also having extensive regulatory compliance experience. Mark has trained thousands of people around the world and bases all of the lectures on the practical experience of the Honeyman Group in these fields, so ensuring that the training is always up to date and built upon real life experiences.

Gavin Ross B Eng, AMIMechE, Process Validation Manager, Honeyman Group Ltd

Prior to joining Honeyman Group, Gavin worked in the pharmaceutical and medical device industry for ten years, at Convatec and Smith and Nephew Medical Ltd. He has had a variety of engineering roles during this time including Plant Process Engineer, Project Engineer, Site Sterilisation Engineer, Validation Specialist and most recently as Validation and Change Control Manager. Gavin brings with him a broad range of validation experience including 21CFR part 11, Conversion Processes, Water Systems, Air Handling (HVAC), cleaning and aseptic manufacture. He also has extensive experience of risk assessment techniques including hazard analysis (HACCP/HAZOP), failure modes effects and criticality analysis (FMECA).

In addition to the leading course tutors, other well-qualified and experienced speakers from industry will be present throughout the course.

The course language will be English.

Who should attend?
The satisfactory design, installation, validation, maintenance and management of sterilisation processes demands a multi-disciplinary team approach. The course will be relevant for:

• Validation and engineering professionals involved in sterilisation processes.

• Microbiologists responsible for biological data and the use of biological indicators.

• QA/QC personnel involved in the review and acceptance of sterilisation data.

• Technical and regulatory compliance and validation support staff.

• Sterilisation system owners and users.

Course Programme
Beginning with an understanding of the microbiology involved, what we are trying to achieve by sterilisation, what is meant by 'sterile' and what sterilisation techniques are available, the course then illustrates how these techniques are applied through appropriate engineering to ensure reliability in full compliance with all European and US regulatory requirements. Finally the ongoing operational, maintenance, thermal and biological validation requirements will be explained in detail. The course content includes:

• Introduction to sterilisation

• Principles of moist heat sterilisation

• Steam quality

• Dry heat sterilisation and depyrogenisation

• Instrumentation and control of sterilisation processes

• 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

Upon Completion of the Course, Delegates Will:

• Have a thorough understanding of Moist Heat and Dry heat sterilisation and depyrogenation technology from first principles to the design of current systems.

• Understand the regulatory framework and expectations for the design and validation of such processes.

• Be aware of the potential problem and failure areas and implement strategies to avoid them.

• Be able to plan and execute the most efficient validation, engineering and regulatory compliance approach to ensure reliable operation, meeting production demands and regulatory expectations.

The Venue
Rochestown Park Hotel, Cork, Ireland
Tel: +353 (0) 21 489 0800,     Fax: +353 (0) 21 489 2178,     Web: www.rochestownpark.com

The Rochestown Park is a luxurious manor style hotel with mature gardens, incorporating 163 rooms, an award winning health and leisure centre and Ireland's first Thalasso Therapy Clinic. The hotel is only five minutes from Cork Airport.

Course Fees and Reservations
The fee for the course is £1,325.00 sterling (€1,990.00) plus VAT where applicable. This covers all tuition fees, comprehensive course notes, refreshments and lunch. A course certificate of attendance is issued to each delegate who attends the full course. Delegates should arrange their own dinner, bed and breakfast, as accommodation is not included in the course fee. The hotel will offer a conference discount rate if you mention that your are a delegate. Reservations not confirmed by payment within reasonable time will be allocated to any persons on a waiting list. Payments should be made by cheque to Honeyman Group Ltd.

Discounts

Book early and receive a 10% discount if payment is received 6 weeks in advance of the course commencement date.
Discounts are also available for multiple bookings, and for government and regulatory agency employees - please contact us for details.

Cancellations

Written cancellations will be accepted up to 31 days before the date of the course, after which a cancellation fee will be payable. Unfortunately no refund can be made for cancellations within 10 working days of the course start date and the full course fee will be due for delegates who fail to attend. Substitutions may be made at any time up to the start of the course, free of charge.
 

We reserve the right to change the programme, speakers, date or venue without notice, or to cancel an event. If cancellation occurs delegates will be notified as soon as possible and will receive a full refund of fees paid. Honeyman Group Limited will not be responsible for transportation, accommodation or other costs incurred due to cancellation.

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