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Advanced Sterilisation
- Validation and the Application of Biological Indicators
Intensive 2½ Day Course
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DATE |
LOCATION |
COST |
RESERVE |
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15th - 17th December 2010 |
Novotel, York, U.K.
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£1,295.00 (€1,815.00) + VAT |
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15th - 17th June 2011 |
Honeyman Group Ltd, Barnard Castle, U.K |
£1,295.00 (€1,815.00) + VAT |
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Course Description:
The validation of sterilisation processes is becoming an
increasingly expensive and time-consuming exercise. Developing the correct strategy for
the validation and planning the approach up front will significantly reduce
problems and expense in the execution stage. Building upon the foundations
delivered by our "Sterilisation - Principles in Practice" course, this two and a
half day training course delivers a comprehensive review of the performance qualification (PQ) of
sterilisation processes, including both thermal and biological validation.
The
course utilises many practical experiences and case studies of validation
exercises on a number of different sites, dealing with different regulatory
bodies. Delegates have found this practical "real world" approach invaluable on
previous courses that have been ran successfully throughout Europe.
Course Programme:
A summary of the course content is as follows:
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Validation strategies and protocol
preparation
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Planning the validation workload for the
most efficient delivery
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Data logging and thermal measurement
calibration and validation requirements - Validating the Validator
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Biological Indicator (BI) application
examples
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BI population and D-value verification
requirements
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BIs for porous load, fluid loads and stopper
cycles
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Understanding the product effect on the
D-value of biological indicators
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Direct Inoculation case study and validation
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Validation of stopper sterilisation cycles
using stoppers which have been directly inoculated
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Top 10 issues with sterilisation validation
and how to avoid them
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Strategies for handling and reporting
deviations
Case Studies:
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Validation of
stopper sterilisation cycles. Direct inoculation of stoppers vs BIs.
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Fluids Validation.
Product effect on D value of micro organism. Use of Bioburden data.
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Using biological
validation data to reduce cycle times on fluids cycles. Cycle efficiency.
Upon Course Completion,
Delegates Will:
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Be aware of the current expectations for the
validation of sterilisation processes
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Be able to plan and execute the most
efficient and compliant validation study
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Understand how to handle deviations and out
of specification results
Who
Should
Attend?
The course is designed specifically for:
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Validation and engineering professionals
involved in or responsible for the validation of sterilisation processes
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Microbiologists responsible for the biological
data and the selection and use of Biological Indicators
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Quality Assurance Managers involved in the review and
acceptance of validation data
Other Courses You May Be
Interested In...:
Course Leaders:
Mark Thompson C.Eng. MIEE BSc
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 BEng: AMIMechE
Operations Director, Honeyman Group Ltd
Heading up the Honeyman Group’s Technical Operations Division, Gavin is now
heavily involved in conducting site feasibility studies and risk assessments for
a number of major clients across the world. Specialising in sterile product
manufacture and aseptic processes, Gavin spent the early years of his career
with leading household names such as Smith and Nephew. Gaining a wealth of
experience in the fields of engineering, QA validation and latterly change
control, Gavin was involved in several major projects relating to technical
change and new technology introduction, cleanroom design and specification and
site wide change control management.
Dave Chadwick
Senior Microbiology Consultant, Honeyman Group Ltd
Roles with some of the World’s leading research based companies including Shell
And GlaxoSmithKline, followed by five years with Honeyman have resulted in Dave
gaining an impressive knowledge of microbiological analysis, interpretation and
troubleshooting. As the Honeyman Group’s Senior Microbiology Consultant, Dave
has taken the lead role in a number of pioneering projects which have resulted
in the development of new methods and techniques aimed at overcoming problems
with existing standards and increasing the accuracy of the microbiological
analysis of raw materials, finished products and medical devices. Since
the introduction of ASTM:2500, Dave has been increasingly involved in a number
of risk based studies commissioned by clients to identify opportunities to
minimise analytical testing and has latterly been instrumental in the
establishment and operational management of the Honeyman Group’s new analytical
laboratories in Dublin, Ireland.
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.
Honeyman Group Ltd, Barnard Castle, UK
Tel: +44 (0)1833 690101, Fax: +44 (0)1833 690102,
Web:
www.honeyman.co.uk
For courses held in our purpose built facility in our Barnard Castle Head
Office, we recommend the Jersey Farm Hotel for those who require accommodation.
We offer delegates a pick up and drop off service to and from the hotel and our
office on the course days.
The Jersey Farm (Tel: +44 (0)1833 638223, Fax: +44 (0)1833 631988,
www.jerseyfarm.co.uk) is situated in its own grounds within
10 acres of farm land, just a two minute car journey from the centre of Barnard
Castle, an historic market town full of character built around the 12th Century
castle from which it takes its name.
Course
Fees and Reservations:
The fee for the course is £1,295.00 sterling (€
1,815.00) + 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. Cancellations received and confirmed by the Honeyman
Group will incur a 20% fee up until 31 working days before the start date
of the course, after which a sliding scale of further cancellation fees will be
applied. No
refund will 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.
