“ISPE is the international society of choice for technical professionals in the regulated heath 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.”
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Issue
No. 28
Autumn
2003
MIDLAND HOTEL,
MANCHESTER
13TH OF NOVEMBER 2003
'Lean Compliance - Cost Effective Manufacturing in a Highly Regulated Environment'
SEMINAR AGENDA
Keynote: Leveraging the Value of
Validation
David Selby,Selby Hope International,ISPE Vice Chair
SEMINAR RESERVATIONS
Seminar Reservations should be made via:
Dr Phillip Richardson
(c/o Ellen Woodward)
Benchmarking and Control of GMP
Performance
Prof Roger Benson, ABB Eutech Process Solutions
Manufacturing Case Study -Risk
Assessment in Supply Chain
Management
Ian Williams, CP Pharmaceuticals
Integrated Construction and Start-up for
Faster, Cost Effective Projects
Kevin Hill, AstraZeneca
Application of the "C&Q Baseline Guide"
to Streamlining Validation
Lynn Edwards, ABB Eutech and Nigel Cryer, Danzas
Disposable Pharmaceutical Processing
Technology: Compliance and Economic
Case Study
Miriam Monge, Stedim
Process Analytical Technology and
Science Based Compliance
Steve Hammond, Pfizer
This
Newsletter is
sponsored by
The Regulatory Response
Liz Allanson, MHRA (UK MCA)
AstraZeneca,
H200 Alderley House
Alderley Park,
Macclesfield
Cheshire
SK10 4TF
Tel: 01625 515042 - Fax: 01625 584172
e-mail: ellen.woodward@astrazeneca.com
The cost of attending the seminar is £98 for members and £118 for non members
Cheques should be made payable to.
ISPE North West Region
WILL ALL SEMINAR DELEGATES PLEASE
NOTE THAT ALL SEMINAR FEES MUST BE
PAID PRIOR TO THE EVENT
ISPE Notice:
The speakers engaged to present at ISPE programmes are leading professionals in their field.
Should it be necessary, substitutions may be made.
SPONSORS FOR THE SEMINAR
BINDERS ARE:
MITIE Science Projects
SPONSORS FOR THE ANNUAL DINNER RECEPTION ARE:
CP Pharmaceuticals Ltd
Glatt Protech Ltd
Gleeds
Industrial Technology Systems Ltd
In conjunction with this technical event, there will be
an Exhibition of equipment and service
suppliers.This Table Top Exhibition will be open during Registration, Coffee Breaks and the Lunch
Period
Ove Arup & Partners
Pharmaplan Ltd
SembCorp Simon Carves
ISPE PHAMA CROS SWORD
1
2
3
6
4
7
Across
5
8
9
10
12
15
16
13
14
4. How much paper does it take to enlarge
the hole? (4)
2. BT's T.V. word. (7)
6. The basic material for heating the water. (7)
4. A short recommendation for lubricating
the gun. (6)
9. Is it the tiniest bit confused when in a
deep sleep? (6)
12. Asthma suffers hate it. (6)
15. What the grease monkey wipes his hands
on. (3-3)
17
18
19
1. The right environment for asepsis. (5-4)
11. Take away knowledge to make a fuel
from an inert gas. (5)
11
20
18. Doesn't sound like the composer of pure
water music (5)
19. Very small to be in charge of the usual.
21
22
21. Acidic tin. (7)
23. What you do with your fury. (4)
24. The reverse of pure water. (7)
23
24
NOTES FROM YOUR EDITOR
Nick Argent has delivered the crossword and we
will print the answers in the next issue (if he lets me
in on what they are!)
The emphasis in this issue is on this year's Annual
Dinner Seminar and I can only emphasise if you are
attending the Dinner it makes sense to make a day
of it and book for the seminar and if you have a
dinner table to encourage your guests to book as
well.
Again any employment changes or seeking of
employment etc. can be registered here as can be
Down
1. A spacecraft made of gelatin? (7)
3. Keep the web in close proximity. (1-1-1)
5. Our governmental representatives. (1-1-1-1)
7. A viral consumer? (5)
8. Settle at H.Q. without a ….. (4)
10. The service industries all want smaller
ones(9)
13. The first half of the brightest globular
cluster (6)
14. Ties the bits together. (8)
16. The most unusual of all. (6)
17. Spraying bullets or tablets? (4)
20. Us (1-1-1-1)
22. Everything in solution. (1-1-1)
PEOPLE & POSITIONS
Andrew Parry, PharmaServices International Ltd.
Tel: 01484 305425
Following a recent redundancy I aim to provide a professional technical pharmaceutical consulting service using my 17 years experience working in multi disciplined roles. These included design, project management and sales / commercial at a senior management level. Previous experience with a world leading
supplier of bespoke pharmaceutical containment solutions involved working
worldwide representing the company both pre and post order, whilst effectively
managing some complex and sizeable projects. Recent experience includes contributing to the development of all types of down-flow containment booths.
Currently available to provide technical consultation, project management and
expediting services on any type or size of containment project.
seen opposite.
Gleeds are recruiting
You can contact either of us at the following num-
Due to the continuous expansion in workload, Gleeds are looking to recruit
experienced Cost Engineers / Quantity Surveyors with knowledge of the
Pharmaceutical and Petro Chemical industry. Experience in both Cost and
Commercial is essential to work within existing office and site based teams within the Northwest. Long term staff positions are preferred but contract would be
considered.
bers and emails:
Lindon Roberts - Editor
Tel: 01606 597520 or 07979 702445
e-mail: lindon.roberts@mitie.co.uk
Nick Argent - sub-Editor
Tel: 01606 49784 or 07808 543134
Please contact: Natalie in our Warrington office - e-mail:
natalie.lloyd@gleeds.co.uk
e-mail: natargent@aol.com
Have you visited the ISPE UK website recently?
h t t p : / / w w w. i s p e . o r g / u k /
RECENT MEMBER CHANGES
Recent role changes/additions to the ISPE NW
Region Committee
Jim Durkin is now Project Director with Powderject
Pharmaceuticals, Gaskill Road, Speke, Liverpool, L24 9GR.
Tel: 0151 705 5000Jim.- Durkin@powderject.com
Lynn Edwards is Principal Consultant with ABB Eutech, Daresbury
Park, Daresbury, Warrington, Cheshire, WA4 4BT.
Tel: 01925 741111 - e-mail: lynn.edwards@gb.abb.com
Lewis Walker, Technical Manager at Jacobs Engineering Ltd.
Stockport has joined the NW Region Committee.
Tel: 0161 741 7855 - e-mail: lewis.walker@jacobs.com
An addition to the ISPE NE Region Committee is:
Richard Paynter of Sanofi-Synthelabo Tel: 0191 21333134
email:richard.paynter@ sanofi-synthelabo.com
ANNUAL SEMINAR, EXHIBITION AND DINNER - MANCHESTER 13TH November 2003
REMINDERS FOR ALL PARTICIPANTS.
1. Book Hotels if not already done.
2. Remember to pre-order your wine for the Dinner
3. Return menu's to Erica if any special diet is required.
Any dinner guests who arrive in Manchester in the afternoon will be most welcome tovisit the exhibition in the Alexandra
Suite at the Midland Hotel.
Any queries Contact: Erica N. Evans-TTerlecki. 123 Heathfield Road, West Moors, Ferndown, Dorset, BH22 0DE
Tel: 01202 876274 Fax 01722 323222 and e-mail: erica.evans@cielec.com Courtesy of C.I.Electronics Ltd.
NOTE FOR YOUR DIARY 2004
11th November 2004 Annual Seminar/Exhibition and Awards Dinner.
This event will be held in the brand new Hilton Hotel, Newcastle-upon-Tyne. The hotel is situated in
the newly regenerated part of the city with the Gateshead Millenium (Blinking Eye) Bridge within its
sight. There are many hotels within walking distance of the Hilton at a range of prices, and we will
be making arrangements with them for the event.
Erica will be taking reservations for this event from 1st December 2003.
Tel: 01202 876274. - e-mail: erica.evans@cielec.com
DIARY OF EVENTS 2003
Southern Region
Chairman
Mark Shaftesley
Tel: 01980 612564
Nov. 2003
Flexi-lab Design.
Venue GSK Stevenage.
Jan/Feb 2004
Seminar on 21CFR11Venue tba
Central Region
Chairman
Roger Shillitoe
Tel: 02476 862529
9th Oct 2003
Introduction to Pharma Industry Part 2Secondary Pharmaceuticals to look at the
secondary processing of pharmaceuticals to
manufacture soliddosage forms.
December 2003
Part 3 of the Introduction to the
Pharmaceutical Industry. This seminar will
overview the Biopharmaceutical and
Biotechnology processes used in the pharmaceutical industry.
Date to be confirmed.
A seminar is planned to take an overview of
ICH Q7a Guidelines on Active
Pharmaceutical Ingredients and the implications for API Manufacturers.
North West Region
Chairman
Philip Richardson
Tel: 01625 516868
1st Oct. 2003
Joint ISPE/IChemE Day Seminar on "The Ins
and Outs of Drying and Granulation in the
Pharmaceutical Industry"Venue: The
Museum of Science & Technology in
Manchester.
13th Nov. 2003
ISPE Annual Awards Dinner,Seminar &
Table-top Exhibition. The title of the seminar
is "Lean Compliance - Cost Effective
Manufacturing in a Highly Regulated
Environment" Bookings: handled by:Ellen
Woodward, AstraZeneca, H200 Alderley
House, Alderley Park, Macclesfield Cheshire
SK10 4TF
Tel: 01625 515042
Fax: 01625 584172
e-mail: ellen.woodward@astrazeneca.com
Venue Midland Hotel Manchester
North East Region
Chairman
Michael Byrne
Tel: 0191 233 2950
03 November 2003
Visit to the Nuffield Hospital, Leeds and a
talk on the Procure 21 approach to NHS
Facilities.
End November 2003
Visit to Avecia Pharma, Teeside.Associated.
Seminar by DEWJOC/Clean Design+others