Pharmaceutical Water Systems: Principles in Practice
March 2008 & October 2008
Intensive 3-day course
[Download Course Brochure (303Kb)]
|
DATE |
LOCATION |
COST |
|
11th - 13th March 2008 |
Novotel,
York, UK |
£1,325.00 (€1,990.00)
+ VAT |
|
7th - 9th October 2008 |
Tara Towers
Hotel, Dublin, Ireland |
£1,325.00 (€1,990.00)
+ VAT |
Introduction
Water is used throughout the Pharmaceutical industry, as a raw material,
a process intermediate, product ingredient, or as a finished product itself. Its wide
use in many applications demands that manufacturers look very closely at
regulatory requirements, specifications, purification methods, installation and
validation. Water systems are always a major area of interest during regulatory
inspections and still represent a significant cause of many non-compliance
issues.
'Principles in Practice 2007' is the latest in the successful series of
pharmaceutical water courses and workshops developed and presented by the Honeyman Group,
who are recognised leaders in the field of high purity water systems. The
course material is constantly updated to reflect the latest regulatory and
cGMP guidelines and expectations and presents a complete overview of best
industry practices in the design, installation and routine operation of high
purity water systems.
Course Tutors
Andy N Marshall CChem, CSci,
MRSC, BSc
Technical and Quality Director, Honeyman Group Ltd
Trained as an analytical
chemist, Andy joined Glaxo's Barnard Castle factory in 1990 and was involved
with stability testing and formulation development before moving to Sanofi.
At Sanofi, he was involved with cleaning validation before becoming the
Equipment Validation Manager. Andy then moved to primary pharmaceutical
manufacture with Chirex as the Validation Co-ordinator, and latterly as the
Operational Quality Manager at the Dudley, Newcastle and Annan, Scotland sites
for Rhodia Pharma Solutions (RPS) and Shasun Pharma Solutions (SPS). Andy
also spent a period of time in New Jersey, U.S.A. developing the quality systems
for the newly acquired pilot plant for RPS. Andy brings a broad range of
validation (in both primary and secondary pharmaceutical manufacture) and
quality assurance knowledge, including FDA and MHRA audit readiness activities
and involvement.
Mark Thompson C.Eng. MIEE BSc
Managing Director, Honeyman Group Ltd
Mark's
engineering background in the Pharmaceutical and Medical Device Industries
includes Eli Lilly, Rhone Poulenc Rorer and Smith & Nephew Medical, specialising
in Sterilisation Technology, Engineering and Microbiology, and 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, ensuring that
the training is always up to date and built upon real life experiences.
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.
Who should Attend?
The course will raise practical understanding and awareness for all
personnel involved in pharmaceutical water systems, including:
-
System owners and users;
-
Engineers involved in design, installation, validation and routine
maintenance;
-
Technical and validation personnel
-
Personnel involved with risk
assessment, troubleshooting and auditing activities for high purity water
systems;
-
Microbiologists, Quality Assurance/Quality Control and
Regulatory personnel
Course Programme
This course presents an
independent view of the design, qualification, validation, operation, management
and maintenance of high purity pharmaceutical water systems and provides an
interactive mix of lectures and workshops. Subjects covered include:
-
Pharmacopoeial water
qualities (USP, Pharm.EUR) and their applications (purified water, bulk WFI,
WFI etc)
-
Basic microbiological
aspects of high purity water systems
-
Purification methods for
high purity water
-
Sanitisation of
pharmaceutical water systems:
-
Approaches to water system
validation:
-
Maintenance of water
systems:
-
Quality systems associated
with high purity pharmaceutical water installations:
-
Routine QC of high purity
pharmaceutical water installations:
-
Biofilms - properties and
significance
-
Auditing water systems and
preparing for a regulatory inspection:
-
Future concepts -
HydroGienic®: a new
solution for cost effective water distribution systems
-
GMP
aspects of sanitary equipment e.g. piping and valves:
-
Instrumentation and controls:
Upon Course Completion, Delegates will:
-
Understand the regulatory requirements,
standards and expectations for high purity water systems
-
Learn about common problems and
how to avoid them;
-
Understand how to design,
build, validate and manage water systems cost effectively;
-
Be able to compare different
strategies for generation, pre-treatment, storage and distribution of
pharmaceutical water and choose the best for your application..
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.
Tara Towers Hotel, Merrion Road, Dublin 4, Ireland
Tel: +353 (0) 1 269 4666, Fax: +353 (0) 1 269 1027,
Web:
www.taratowers.com
The course will be held at the Tara Towers Hotel, a 3
star hotel located just 3km south of Dublin city centre along the curve of
Dublin Bay with beautiful views of sea and shore. The hotel is ideally located
with easy access to Dublin's City Centre via the "Dart Line" for fast and
reliable transport.
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 book 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.