Sterilisation:
Principles in Practice
Intensive 3-Day Course
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DATE |
LOCATION |
COST |
RESERVE |
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9th - 11th February 2010 |
Rochestown Park Hotel, Cork, Ireland |
£1,575.00 (€2,205.00) |
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7th - 9th September 2010 |
Novotel, York, U.K. |
£1,575.00 (€2,205.00) |
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Course Description:
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 examined.
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.
'Lecturer’s
knowledge of topics discussed and all related and/or ancillary subject matter
related to our industry was boundless, his expertise is unrivalled'
Serum
Processing Technician,
Immucor Inc, Atlanta, USA
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.
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.
Other Courses You May Be Interested In...:
Course Leaders:
Mark Thompson B.Sc. (Hons), C. Eng. M.I.E.E. Managing Director,
Honeyman Group Ltd
Mark's prolific background in the pharmaceutical
and medical device industry spans more than twenty years. Various engineering
management roles with the world’s largest household names including Eli Lilly,
Rhone Poulenc Rorer and Smith & Nephew Medical have seen Mark leading
engineering teams through an array of engineering projects driven by capacity
relief, new product introduction, profit improvement and regulatory compliance.
A Chartered Engineer and Member of the Institute of Electrical Engineers, Mark
primarily specialises in control and instrumentation projects within sterile
manufacturing operations.
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.
Course Language:
The course will be delivered in English.
The
Venues:
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.
Novotel York, Fishergate, York, YO10 4FD
Tel: +44 (0) 1904 611660, Fax: +44 (0) 1904
610925, Web:
www.novotel.com
The Novotel York is a modern hotel situated on the
banks of the River Foss and within walking distance of all the major attractions
in one of England's favourite tourist destinations. London's Kings Cross is
approx. 2 hours away, there is a rail link to Manchester Airport and
Leeds/Bradford Airport is convenient. York is easily accessed from major
national roads. Parking and leisure facilities are available.
Course Fees and Reservations:
The fee for the course is £1,575.00 sterling (€2,205.00)
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 it is not included in the course fee. Remember, when
reserving your accommodation to mention that that you will be attending a
Honeyman course, this will entitle you to the discounted room rates that we have
negotiated for you. For ease and convenience, we recommend that you stay in the
hotel which is hosting the course. However, alternative accommodation can be
arranged, details of which can be obtained from the local tourist information
centre.
Booking Conditions
Book early and receive a 10% discount if payment is received 6 weeks
prior to the course start date. Further discounts are also available for
multiple bookings and for government and regulatory agency employees - please
contact us for details. Written cancellations (received and confirmed by
Honeyman Group Ltd) will be accepted up to 31 working days before the start 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, (even
if the course fee has yet to be received). Substitutions may be made at any time
up to the start of the course, free of charge.
Reservations not confirmed by payment by the course start date will be allocated
to any persons on a waiting list. Payment can be made by bank transfer or
cheque. Alternatively register via our website and pay by credit/debit card.
We reserve the right to change the programme, speakers, date or venue without
notice, or to cancel an event. In the unlikely event of cancellation occurring,
delegates will be notified as soon as possible and will receive a full refund of
fees paid. Honeyman Group Ltd will not be responsible for transportation,
accommodation or other costs incurred due to cancellation. We reserve the right
to charge an administration fee to those delegates who fail to attend a course
through no fault of Honeyman Group Ltd, but wish to have their place transferred
to the next available course.
To reserve your place, please complete a
Registration Form and a Payment Details
Form and forward to Honeyman Group Ltd by either by post, fax or e-mail. Or
register via our website at www.honeyman.co.uk Upon receipt of registration,
Honeyman will forward written confirmation and VAT invoice.
Receipt of this form by Honeyman Group Ltd consists a binding registration.
To avoid disappointment an e-mail/telephone/fax reservation is advisable prior
to sending your booking form and payment.
