“ISPE is the international society of choice for technical professionals in the regulated health care 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.”
Brian Sixsmith, In Memoriam - By Roger Trew
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Issue No.
58
Summer
2012
It is with great sadness
we learn that Brian
Sixsmith
died
on
Friday the 8th June
2012, following a long
illness.
“Brian was passionate
about ISPE and the benefits it could bring. He
was a pleasure to work
with and was the glue
that held it all together in
the early days”
Brian was one of the
finest gentlemen it was
my pleasure to know
and work with, and be
able to call a true friend
and colleague
The many years of
invaluable input and
commitment Brian gave
to the UK Affiliate will
never be forgotten, and
resulted in him being
awarded the ISPE UK
Fellow Award, in recognition of these efforts, in
2001.
As one of the prime initiators of the ISPE UK
Affiliate in 1989 Brian
undertook most of the
administrative
and
legal work associated
with finally establishing
the Affiliate in 1990.
As first Affiliate Secretary,
Brian
guided
many
Chairmen (including myself)
through their periods of
Office and, other than a period as Chairman, he held the
post until recently when illness prevented him from
continuing.
In the words of Bob Best,
Past President of ISPE
International and with
whom Brian worked in
establishing
the
UK
Affiliate,
Brian will be remembered each year at the
Annual Awards Dinner
and it is a fitting tribute that
the Fellow award was
recently
renamed “The
Brian Sixsmith Fellow
Award” in recognition of his
contribution to the UK
Affiliate.
ISPE UK AFFILIATE BOARD 2012/2013
Following the AGM the following Officers of the UK Board are now confirmed. For more information please refer to the UK affiliate website www.ispe.org/uk
Chair
Event Organiser
Regional Chairman
Bruce Williams
Williams Process
Philip Booker
The Event Bookers
Deputy Chair
Student Member
Coordinator
North East
Dr Peter Dodd
FujiFilm Diosynth
Biotechnologies
Lynn Bryan
Provimi Ltd
Secretary
Roger Shilitoe
CEL International
Jon Youles
Ytron-Quadro (UK)
Affiliate Education
Advisor
Treasurer
Dr Michael Cliff
Phil Hill
Northcroft
Newsletter Editor
Membership Secretary
Dr Phillip Richardson
AstraZeneca
Jon Youles
Ytron-Quadro (UK) Ltd
COP Coordinator
Roger Trew
North West
Rob Walker
Rob Walker
GMP Consultancy
Central
Stephen Boswell
S3 Process
Southern
Hugh Butcher
Scitech
ISPE INFO UPDATE - Lynn Bryan – Deputy chair
Chair of the Northwest region.
Lynn brings a great deal of experience
within the pharmaceutical industry to the
role.
She has had Qualified Person status 7
years and is currently working as a QP
for Provimi Ltd a veterinary products
manufacturer.
Lynn Bryan has been appointed as
Deputy Chair of the ISPE UK Affiliate,
with the intention taking on the role of
Chair in 2013.
Lynn has been involved with the ISPE for
more than 10 years at Regional
Committee and Affiliate level and was
Previously Lynn was the Quality Manager
for a radiopharmaceutical manufacturer
and as the validation manager at Ipsen
Biopharm, a pharmaceutical company
manufacturing blood products and vaccines in sterile liquid and freeze dried
form. Lynn also worked as the production support manager responsible for calibration, validation and new product introduction at a contract aerosol
manufacturing company. The company
produced MDI’s, DPI’s, pump spray and
aerosol products to the US and Europe.
Lynn was the director of an independent
validation company; she has also worked
for Wellcome and Fisons in both production and QA roles. She has been presenting on training courses on validation,
training approach, GMP and water/steam
systems for over 10 years.
On her appointment, Lynn said, “I look
forward to the responsibilities of my role
as Deputy Chair and intend to support
the hard work of the UK Affiliate. I hope to
enhance the benefits of ISPE
Membership in what is a challenging
environment for the pharmaceutical
industry”
COMMUNITIES OF PRACTICE
The UK currently has four active Communities of Practice (CoPs), namely GAMP, Sustainable Facilities, PAT and Project
Management.
If you would like to find out more information on the full range of CoPs or to get involved then details can be found on the ISPE
website www.ispe.org/COP
PAT
As part of the roles of the task team as Survey on QbD benefits has been completed and results will be published by ISPE very
soon.
Three new task teams have been formed
Modelling: Transfer, Maintenance, Lifecycle Implementation and Regulatory Implications
Continuous Processing: The team will agree and communicate on the topic that they will address first.
Process Validation, Stage 3: Team will present alternatives ways / tools that companies could utilize to address Stage 3 of
process validation
An excellent CoP meeting, hosted by Genzyme, was held on May 24 inlcuding a tour of the facilities and technical discussions.
The next meeting will be hosted by BMS in Liverpool on October 2, 2012.
GAMP
GAMP UK held its Spring meeting on 26th April in Reading, sponsored by CTG. The 56 delegates enjoyed a lively and interactive
session sharing regulatory inspection experiences, as well as hearing about cloud computing, the revision of the Testing and
Laboratory guides, testing of blood systems, non-linear development lifecycles and promotional practices.
The next meeting will be on 2nd October, hosted by AstraZeneca. The meeting will include presentations on infrastructure management and team working, and an interactive workshop on Risk Management as well as a number of round table discussions on
industry hot topics such as mobile apps. The Spring meeting was over-subscribed so register now for the October meeting to be
sure of a place - please email your details to gampukcop@gmail.com or visit the ISPE Global Event Calendar for more details.
GAMP celebrates its 21st birthday this year - with the 5th edition it has certainly come of age. I hope all the "GAMPers" out there
will join me in raising a glass to celebrate the incredible success GAMP guidelines have had globally, and to thank all the volunteers who work so hard supporting GAMP meetings and conferences."
Sustainable Facilities
The new Energy & Environment Task Team, a collaboration between the HVAC and Sustainable Facilities COP is progressing with
its work to address the “Actual and perceived internal and external compliance barriers prevent significant reduction of energy consumption in life-science facilities”
The aim is to develop a guidance document for improving energy efficiency and reducing life-cycle costs of controlled environments
for life science facilities as well as develop a guidance document based o a number of Knowledge Briefs including; History of cleanrooms, scientific risk based approach and case studies on performance/overperfomance.
If you would like more information, please contact the EETT lead, Nigel Lenegan at nigel.lenegan@energyandcarbon.co.uk
The Annual Awards Conference, Exhibition and Dinner Thursday 22nd November 2012
Hotel rooms are available
at special ISPE rates
The Annual Awards Conference and
Exhibition will take place at the Harrogate
Majestic Hotel, Ripon Road, Harrogate,
and the Dinner will be held at the
Harrogate International Centre on
Thursday 22nd November 2012.
Hotels rooms are available at special
ISPE rates from £84.00 to £130.00; all
prices are per night and include
Breakfast and VAT.
The theme for the conference is
Competitive Advantage from
Risk Based Approaches.
For all aspects of booking please contact
Philip Booker
The seminars will take a holistic view of
how risk based approaches have given
real benefits to the bottom line, as well as
improving quality, safety, productivity and
plant reliability.
Exhibitors’ spaces from £330.00
ISPE United Kingdom Affiliate Limited
Individual places £95.00
6 Gorse Close,
Confirmed speakers include :
Conference places from £140.00*
Table from £950.00 - £1140
Early bird special from £185.00*
Ali Afnan, Step Change Pharma (formerly of FDA)
Locks Heath,
Southampton,
Hampshire SO31 6XZ
Telephone 01489 571213
email philip@bookerevents.co.uk
Gill Turner, GlaxoSmithKline
Alf Penfold, Pfizer Global Engineering
The Exhibition and Seminars will be held
at The Majestic Hotel,
Dr Phillip Richardson, AstraZeneca
with the Awards Dinner at The Harrogate
International Centre.
Tony Hitchcock, Cobra Biologics
* ISPE Member prices
Peter Marshall, AstraZeneca
The ISPE is not VAT registered.
Dr. Kit Erlebach, Fujifilm Diosynth
Biotechnologies
DIARY OF EVENTS 2012
Region Contacts
2012 Annual Conference &
Awards Dinner
North West Region
Chair – Rob Walker
T: 01244 571 515
E: robwalker.chester@btinternet.com
Southern Region
“Competitive advantage from risk
based approaches”
Harrogate, 22 November 2012.
FUJIFILM Diosynth
Biotechnologies
For information on the available training
programmes please visit the Knowledge
and Learning section.
PPMA EVENTS & NEWS
Site Visit, Talks, and Networking,
Billingham - September / October
PPMA 2012
at the NEC
25th – 27th Sep 2012
North East Region
Brewery Tour and Social event
PPMA Seminar series
Chair – Peter Dodd
T: 07711 445 299
E: Peterw.Dodd@fujifilmdb.com
Double Maxim Brewery
Houghton-Le-Spring – December
PUWER
Marriot Hotel, Northampton
6 September 2012
Central Region
Chair – Steve Boswell
T: 07891 485368
E: sboswell@s3process.com
The ISPE UK Affiliate will be continuing
to develop the programme of educational events aimed at providing cost effective training.
The event calendar is continually under
development. More details are available
on the ISPE website www.ispe.org/uk
Our intention is to hold a series of 2 day
training courses with the next topic
being Pharmaceutical Water Systems
Chair – Hugh Butcher
T: 07980 817753
E: hugh.butcher@scitech.com
Education and Training
Machinery Directive
Manchester Airport Marriott Hotel
8 November 2012
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
Advertising opportunities available
For more information on how to reach
your potential clients
Please contact the Newsletter Editor
Jon Youles
E: jony@ytron-quadro.co.uk
T: 07711 633105
www.ispe.org/uk
Editor - Jon Youles
Tel: 01494 792898 - Mobile: 07711 633105
Email: jony@ytron-quadro.co.uk