Managing Contamination in Sterile Product
Manufacture
November 2008
Intensive 1½ day course
[Download
Course Brochure (302Kb)]
|
DATE |
LOCATION |
COST |
|
11th - 12th November 2008 |
Honeyman
Group Ltd, Barnard Castle, UK |
£1,025.00 (€1,545.00)
+ VAT |
Course Background
The manufacture of
sterile product, either aseptically or by utilising terminal sterilisation, is a
complex process. Quality and control needs to be 'built in' from the beginning
of this process.
Over recent years,
the application of the 'risk based approach' has significantly improved this control
by:
-
Focusing effort
on the areas of the process that present the greatest hazards. This could
result in those hazards being engineered out of the process, or suitable
control measures being implemented.
-
Improving process
understanding. Analysis of the process by operations,
engineering, QA, validation etc., will identify the value-adding and non
value-adding activities but will also improve overall understanding of the
process.
-
Identifying training needs
and training programmes which can be specifically targeted at process
improvements. These improvements can often be directly measured
in areas such as bioburden control, production efficiency, etc.
-
Delivering GMP compliance in
a more cost-effective and focused manner.
This new course is
designed to introduce these risk-based models to sterile product manufacture.
Through a series of workshops and lectures the process of making sterile product
sterile will be assessed, including examples of where hazards exist and how they can be
eradicated or controlled to an acceptable level.
Application of the
tools discussed in this course can lead to:
-
More efficient
manufacturing processes
-
Improved bioburden control throughout the
process
-
A structure for change control and process
improvements into the future
Course
Programme
The course is
based upon Honeyman’s real world experience of sterile product manufacture and
will draw upon many case studies from work we have completed in improving
contamination control and bio burden control for clients. Some of these case
studies will take the form of team workshops, interspersed throughout the
lectures.
-
Making Sterile Products Sterile
-
Application of ICH Q9 as a framework for the process
-
Understanding the objectives and benefits of risk
management:
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Process improvements, quality, cost and time
-
Validation rationalisation
-
Re-qualification rationalisation
-
Training focus
-
Application of HACCP to contamination control.
Understanding the Critical Control Points.
-
Operation of a HACCP team, documentation practices and
final reporting.
-
How to maintain HACCP as a live system for change control
and process improvements in the future.
-
Application of HACCP data to validation and
re-qualification rationalisation.
-
How to apply risk-based assessments to future operations:
-
Operational procedures
-
Maintenance requirements/spares holdings
-
Calibration requirements
-
Re-validation and re-qualification requirements
-
Corrective and Preventative Action (CAPA)
-
Change Control
Who should Attend?
Anyone involved in the manufacture of sterile product who has a responsibility
for process improvement, including:
-
QA and
regulatory personnel who wish to improve regulatory compliance and product
quality.
-
Engineering
and technical personnel who wish to ensure best practice maintenance and
support based upon true risk assessments, by focusing
engineering effort where required and ensuring maintenance practices add to
product quality rather than detract.
-
Operations
management personnel who wish to improve process efficiencies, training
definitions and product quality/consistency.
Upon Course Completion, Delegates will:
-
Understand the requirements
for contamination control throughout a sterile product manufacturing
process.
-
Learn about different
methods and risk assessment techniques that can be applied to improving
contamination control throughout the process.
-
Understand how to apply risk-based techniques to ongoing support definition. Maintenance,
calibration, validation re-qualification etc.
Course
Leaders:
Mark Thompson BSc (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.
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 training 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 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 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 21 CFR part 11, Conversion Processes, Water Systems, Air Handlinh
(HVAC), Cleaning and Aseptic Manufacture. He also has extensive experience of
risk assessment techniques including hazard analysis (HACCP/HAZOP), failure
mode effects analysis (FMEA) and failure mode effects and criticality analysis
(FMECA).
The course language will be English.
The
Venues
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.
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 Irelands
first Thalasso Therapy Clinic. The hotel is only five minutes from Cork Airport.
Course Fees and Reservations
The fee for
the course is £1,025.00 sterling (€1,545.00) 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 this
is not included in the course fee.
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 and Cancellations
Book early
and receive a 10% discount if payment is received 6 weeks prior to
the course date. 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 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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To avoid disappointment an e-mail/telephone/fax
reservation is advisable prior to sending your booking form and payment.
