“ISPE is the international society of choice for technical professionals in
the regulated healthcare manufacturing industries. We are the leading
world-wide provider of forums and educational services to promote the
development and sharing of technical knowledge and practical experience to benefit our members.”
ISPE UK ANNUAL conference and Awards
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This year the ISPE United Kingdom
Affiliate Northwest Region is looking
at how the pharmaceutical industry is
changing, focusing on keeping both
your knowledge and physical assets
current, in order to stay ahead of
these changes.
The seminar will look at the lifecycle
of the industry, from development of a
new R&D or production capability, through asset
procurement, operation and maintenance, finally
decommissioning and disposal. The seminar will
review this cycle from two perspectives: the typical engineering view, including equipment and
facilities, and the computer system approach with
input from the GAMP COP.
This is an opportunity to update and
refresh your knowledge in key areas
which affect your everyday working
life and future direction.
In order to provide the most benefit,
you will be able to move between the
two streams running during the day,
therefore being able to pick the most
relevant and beneficial to you. A certificate for this
program will be available on request to add to
your CPD. In addition, you will have great opportunities to interact with the speakers, like minded
colleagues and exhibitors during breaks in the
exhibition hall.
Agenda
09:00 - 09:15
09:15 - 09:45
Welcome and Introduction in the Princes Suite
Lynn Bryan Chair ISPE UK Affiliate Northwest Region
Keynote – In search of excellence: opportunities to leverage the UK’s heritage in
bioprocess science and engineering
Dr Crawford Brown, Chief Executive Officer, Eden Biodesign
Site Stream
09:45 - 10:30
10:30 - 11:00
11:00 - 11:45
11:45 - 12:30
12:30 - 14:00
14:00 - 15:00
15:00 - 15:30
15:30 - 16:15
16:15 - 17:00
The Role of Strategic Real Estate in Pharma Industry Life Cycle Management
Paul Youdes - Head of Global Real Estate - AstraZeneca
Refreshments in Exhibition hall
Life Cycle Costing Considerations in Asset Management
Andy Green- Faithful & Gould
A holistic upgrade of the manufacturing and testing processes in a live attenuate
vaccine facility
Mark Proctor. MedImmune
Lunch in Exhibition hall
Human Factors in Maintenance - Identifying Critical Equipment and Assessing Critical
Tasks
Jamie Elliott - Human Factors Consultant, HFL Risk Services Limited
Refreshments in Exhibition hall
Total preventative maintenance - The Essential Partner to Achieve Lean Manufacturing
Peter Willmott - Willmott Solutions
HSE and the Pharmaceutical Industry
HSE Inspector confirmed
GAMP Stream
09:45 - 10:30
Issue No.
10:30 - 11:00
11:00 - 11:45
56
11:45 - 12:30
12:30 - 14:00
14:00 - 15:00
15:00 - 15:30
15:30 - 16:15
Autumn
2011
16:15 - 17:00
The value of Project Management, Planning & Requirements Management
David Stokes, Business and Decision
Refreshments in Exhibition hall
Practical Guidance for Annex 11
Siôn Wyn, Conformity
Operational considerations for a Regulated Company
Nichola Stevens - AstraZeneca
Lunch in Exhibition hall
Risk based approach to testing and C&Q
Karen Ashworth - Karen Ashworth Consulting
Refreshments in Exhibition hall
Managing suppliers and service providers
Chris Reid - Integrity Solutions
Decommissioning Case Study
Chris Clark - Napp Pharmaceutical
For more information on the agenda and registration details please visit
www.ispe.org/uk
ISPE INFO UPDATE
HVAC Training – 4/5 October 2011
The first of the UK Affiliate training seminars is to be
HVAC for Pharmaceutical facilities at the Barcelo Hotel,
Oxford
2-day Course Description
This course will provide a detailed description of HVAC system
fundamentals, including a discussion of primary system components such as fans, coils, humidifiers, and filters.
Participants will receive an overview of critical parameters for
products and processes that can be affected by HVAC, and
explore the basic concepts of controlling these parameters
using properly designed HVAC control systems. Participants
will discuss what HVAC can and cannot do to maintain good
manufacturing practices (GMPs) as they are addressed for
facilities designed to manufacture bulk pharmaceutical chemicals (BPC), oral solid dosage (OSD) products, sterile products,
and bulk biopharmaceuticals. HVAC systems for production
laboratories and warehouse facilities utilized for the storage of
product, raw materials and components are also covered.
On completion of facility-specific systems, the requirements for
commissioning and qualification are explored with emphasis
on distinguishing between critical and noncritical parameters.
Other course topics include HVAC controls, monitoring of critical parameters, and system construction. Dust collection systems and laboratory fume hoods are not covered, as these systems are addressed by other sources. The course concludes
with suggestions for system maintenance
Take Back to Your Job the ability to:
Define basic HVAC system concepts
Discuss HVAC system-critical parameters that must be
controlled and monitored
Distinguish among pharmaceutical cleanroom air classifications and explain how they are applied
Explain the role of HVAC in protecting products
Examine typical HVAC system designs utilized for bulk,
oral solid dosage, sterile, biopharmaceutical, and packaging and warehousing operations
Understand the basics of process laboratory HVAC
Describe HEPA filter theory, application, monitoring,
testing, and repair
Define Pharmaceutical site HVAC maintenance requirements
Cost: Members £695 , Non-members £845
Delegate cost includes:
Course materials
HVAC Good Practice Guide
2 day classroom course (including overnight accommodation with evening meal and breakfast)
For more information on booking please contact: Philip Booker ISPE UK Affiliate Events Manager
T: 01489 571213
E: Philip.booker@ispeuk.org
COMMUNITIES OF PRACTICE
The UK currently has a number of active COPs including Sustainability, GAMP and PAT. For more information on the
Communities of Practice, please visit: www.ispe.org/cops
GAMP
PAT
Building on the success of the meetings to date,
GAMP UK COP's next meeting is on 18th October in
Daresbury, Cheshire.
The members of PAT CoP UK/Ireland will meet on 25th November in
Liverpool, following the Annual ISPE /UK meeting and dinner on Nov
24.
This free of charge meeting is sponsored by ABB,
and features presentations and case studies on the
new Process Control System good practice guide,
on outsourcing, on supplying across regulated and
non-regulated industries, and on moving to a single
Quality Management System. There will also be a
keynote presentation on the ISPE GAMP interpretation of the revised Annex 11.
The meeting will take place between 09:00 and 14:30 at the Crowne
Plaza, Liverpool City Centre.
To reserve one of the last few remaining places, or
to be added to the mailing list for future events,
please contact us at gampukcop@gmail.com.
This is an exciting meeting as there will be a presentation for the task
team on QbD benefits. Last year this task team set off to investigate
the industry’s position on “The business case rationale for using Quality
by Design (QbD )” as different companies seemed to have different
views and approaches. The group interviewed senior managers and
technical experts who have experience of QbD and/or Process
Analytical Technology (PAT) principles. The interviews covered small
and big pharma, small and large molecule and development companies. The results of this work will be presented.
The Annual Awards Conference, Exhibition and Dinner Thursday 24th November 2011
Sponsors for the event are
Hotel rooms are available
at a special ISPE rate
www.cyrilsweett.com
www.davislangdon.com
£130.00
Thistle Atlantic Towers
£95.00
Radisson Blu
£95.00
Hilton
£139.00
Novotel
£105.00
For all aspects of booking please
contact
www.dmwestinghouse.co.uk
Philip Booker
www.epsilonpsl.com
The Event Bookers Limited
6 Gorse Close,
Locks Heath,
Southampton,
Hampshire SO31 6XZ
Telephone 01489 571213
email philip@bookerevents.co.uk
A limited numer of places are still
available for the annual dinner.
Exhibition and Conference bookings
are currently being taken by The
Event Bookers.
Sold out
Malmaison
Jury’s Inn
£89.00
all prices are per night and include
Breakfast and VAT
www.hosokawa.co.uk
The Annual Awards Conference,
Exhibition and Dinner will take place
at the Crowne Plaza, Princes Dock,
Liverpool on Thursday 24th
November 2011.
Crowne Plaza
www.matini.co.uk
www.powdersystems.com
DIARY OF EVENTS 2011
The provisional plans are currently
under development in the regions
and we will be keeping you updated
of any developments through the
ISPE website - www.ispe.org/uk
Central Region
Chair – Steve Boswell
Tel: 07891 485368
Email: sboswell@s3process.com
A full programme of events is being
developed for 2012 including
Lean/Continuous processing and a
series of Introduction to the
Pharmaceutical Industry
North East Region
Chair - Bruce Williams
Tel: 07944 766 508
Email: bruce@williamsprocess.co.uk
Nov 2011:
Cleanroom Facilities
Site tour of clean rooms in facilities specialising in novel technologies.
Location: Netpark, Sedgfield
The agenda for 2012 is under development and includes the 2012 Annual
Seminar and Dinner
North West Region
Cont
Chair – Lynn Bryan
Tel: 07970 004620
Email. lynn@ballygan.com
The programme of events for 2012 is
under review and will include a seminar
on Project Management and a number of
site visits
5 Oct 2011:
Continuous processing
Seminar
The Heath Business and Technology
Park, Runcorn
20 Oct:
Health protection Agency
Site Tour
Venue: HPA, Porton Down
24 Nov 2011:
Annual Awards Conference and Dinner
Operational Effectiveness – A Life Cycle
approach
Venue: Crowne Plaza, Liverpool
Southern Region
Chair – Alan Halstead
Tel : 07879 432587
Email : Alan.Halstead@pmg.co.uk
4/5 Oct:
HVAC Training course
2 day residential training course
Venue: Barceló Hotel, Oxford
8 Nov 2011:
Process Steam
Evening Seminar
Venue: Spirax Sarco, Cheltenham
Q1 2012:
C&Q/GEP
Half Day Seminar
Details to be confirmed
Further events will include site visits and
Data management seminar
PPMA EVENTS & NEWS
PPMA show
Processing and Packaging 2010
at the NEC
27th – 29 Sep 2011
PPMA Ltd.
Tel: 020 8773 8111
www.ppma.co.uk
Don’t forget to visit the website - www.ispe.org/uk
This newsletter is sponsored by the following companies
Editor - Jon Youles
Tel: 01494 792898 - Mobile: 07711 633105
Email: jony@ytron-quadro.co.uk