|
Advanced Sterilisation
- Validation and the Application of Biological Indicators
Intensive 2½ Day Course
|
|
DATE |
LOCATION |
COST |
RESERVE |
|
9th - 11th December 2009 |
Novotel, York, U.K. |
£1,295.00 (€1,815.00) + VAT |
 |
|
|
|
|
|
|
9th - 11th June 2010 |
Rochestown Park Hotel, Cork, Ireland |
£1,295.00 (€1,815.00) + VAT |
|
|
|
|
|
|
|
15th - 17th December 2010 |
Novotel, York, U.K.
|
£1,295.00 (€1,815.00) + VAT |
|
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:
-
Validation strategies and protocol
preparation
-
Planning the validation workload for the
most efficient delivery
-
Data logging and thermal measurement
calibration and validation requirements - Validating the Validator
-
Biological Indicator (BI) application
examples
-
BI population and D-value verification
requirements
-
BIs for porous load, fluid loads and stopper
cycles
-
Understanding the product effect on the
D-value of biological indicators
-
Direct Inoculation case study and validation
-
Validation of stopper sterilisation cycles
using stoppers which have been directly inoculated
-
Top 10 issues with sterilisation validation
and how to avoid them
-
Strategies for handling and reporting
deviations
Case Studies:
-
Validation of
stopper sterilisation cycles. Direct inoculation of stoppers vs BIs.
-
Fluids Validation.
Product effect on D value of micro organism. Use of Bioburden data.
-
Using biological
validation data to reduce cycle times on fluids cycles. Cycle efficiency.
Upon Course Completion,
Delegates Will:
-
Be aware of the current expectations for the
validation of sterilisation processes
-
Be able to plan and execute the most
efficient and compliant validation study
-
Understand how to handle deviations and out
of specification results
Who
Should
Attend?
The course is designed specifically for:
-
Validation and engineering professionals
involved in or responsible for the validation of sterilisation processes
-
Microbiologists responsible for the biological
data and the selection and use of Biological Indicators
-
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
Prior to joining Honeyman Group,
Gavin worked in the Pharmaceutical and Medical Device Industry for 10 years at
Convatec and Smith & Nephew Medical. 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) and Failure Mode Effects and Criticality Analysis (FMECA).
Course Language:
The course will be delivered in English.
The Venues:
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.
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 £1,295.00 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. 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.
