Sterilisation:
Principles in Practice
September 2008
Intensive 3-day course
[Download Course Brochure (306Kb)]
|
DATE |
LOCATION |
COST |
|
23rd - 25th September 2008 |
The Rochestown Park Hotel, Cork, Ireland |
£1,325.00 (€1,990.00) + VAT |
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:
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Validation and
engineering professionals involved in sterilisation processes.
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Microbiologists
responsible for biological data and the use of biological indicators.
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QA/QC personnel
involved in the review and acceptance of sterilisation data.
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Technical and
regulatory compliance and validation support staff.
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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:
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Introduction to sterilisation
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Principles of moist heat sterilisation
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Steam quality
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Dry heat sterilisation and depyrogenisation
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Instrumentation and control of sterilisation processes
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Quality systems associated with sterilisation processes
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Auditing sterilisation processes and preparing for a regulatory
inspection
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Biological Indicators
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Validation strategies for sterilisation processes
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Routine operation of sterilisers
Upon Completion of the Course, Delegates Will:
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Have a thorough understanding of Moist Heat and Dry heat sterilisation and
depyrogenation technology from first principles to the design of current
systems.
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Understand the regulatory framework and expectations for the design and
validation of such processes.
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Be aware of the potential problem and failure areas and implement strategies
to avoid them.
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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.