“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.” Chairman’s Report by Bob Adamson N E W S L E T T E R Issue No. 52 Spring 2010 On completion of my first year as UK Affiliate Chair I can reflect back and look at our achievements over the past year. There is no doubt that times for our industry are extremely difficult. Recent announcements of reductions in two of our major companies have left a lasting impression on the state of our industry. The UK Chair’s role has been both an interesting and challenging experience and quite different from most of my more recent roles at the international level. Organising and running an affiliate of UK’s size in the current climate is not easy with pressure on all our volunteers especially in respect of travel and “prime work” time. However, our society remains strong. Numbers have reduced locally and internationally with a UK membership of just under 1,000. We have seen the effect on our Scottish Region and we have had to take the only decision possible and windup this regional group in spite of the sterling efforts of the Region’s Chair and his committee. The UK affiliate would particularly like to thank Hamish McArthur for all his hard work. Our other regional affiliates remain strong with committed and active members serving on the regional committees. These dedicated volunteers are the "life blood” of our society and we owe them due thanks and recognition for this service. A number of regional chairs stand down this year, Steve Riley, Brian Ravenscroft, Michel Edwards and we welcome Lynn Bryan, Steve Boswell and Alan Halstead to our affiliate committee. We have continued with a number of initiatives and now have 3 active Communities of Practice. The UK has opted to give these substantial supports both in encouragement and financially. Our aim is to continue to focus on providing member benefit and so encourage greater involvement in the society Our connection with the European Affiliate Council and Education in Europe remains strong although we have seen the number of European seminars diminish from 4 to 2. Our increased co-operation with other UK Institutions is improving and working well (I.ChemE, IMechE). This will continue through 2010/11. We face a difficult and challenging period for the industry in the UK and we need to continually review and challenge our own programmes and initiatives so that we are focussed on delivering benefit to our members who are our key resource and customer. COP UPDATE SUSTAINABLE FACILITIES The sustainable facilities COP is an active community holding regular meetings and working in teams to generate guides for best practice, technology and Legislation and Regulation. The CoP is keen to hear from manufacturers with case studies that can be shared and used to help in setting up these guides. For more information and contact details, please see the back page advertisement. The GAMP UK CoP inaugural meeting took place at Pall Life sciences on 29th April 2010. The meeting was well attended and successfully “kick started” the CoP activity The GAMP CoP and Southern Regional Committee are organising a 1 day seminar “GAMP – Meeting the Challenges of Regulatory Evolution” in Bracknell on 16th June 2010. Full details are available on the ISPE website and a limited number of table top exhibition spaces will be available. ISPE INFO UPDATE - NEW REGIONAL CHAIRS SOUTHERN REGION Alan Halstead Alan Halstead has taken over from Michel Edwards as Southern Regional Chairman. Alan is an electro-mechanical engineer working for PM Project Services. He has been involved in the pharmaceutical industry for 12 years providing technical, validation and compliance expertise for Pharmaceutical and Biotech facilities. Alan also spent a number of years in Weapons Engineering. Co-author of “Calibration Management” his recent focus has been on applying Risk MAPP as the guidance is due out in the very near future Alan was Chair of the ISPE UK & Ireland Community of Practice for Process Analytical Technology between 2005 and 2009, and will continue to take an active interest in the PAT CoP. Alan says, “the Southern Region Committee’s main focus this year will be the coordination of the 2010 Annual event and looking to enhance the service to the region’s membership by making use of the specialist technical information from the CoPs and the diverse range of ISPE training packs. This should enable us to provide a much needed review of the technical advances against the revisions of the regulatory and baseline guides for next year.” CENTRAL REGION Steve Boswell Steve Boswell has been elected Central Region Chairman to succeed Brian Ravenscroft and has been involved with supporting the ISPE central region committee for many years. Steve has worked in the pharma and healthcare industry for over 20 years, specialising in solid dosage form processes and containment systems, working for Glatt and GEA Pharma Systems. Steve said, “I have had the pleasure of working on many international projects and sites worldwide, it is a great industry with many talented people, although, going through a significant change the ISPE has an important part to play in that change” Steve has recently started his own process equipment business, S3 Process and Packaging Equipment Ltd, representing manufacturers such a Gerteis, GEA Courtoy and Buck Valves, Krieger and GF amongst others. Steve commented, “I would like our region to focus on communicating process innovation and encouraging the use of new technologies to help improve our product development and m a n u f a c t u r i n g competitiveness in the UK. We have a very experience central committee team with a wide range of skills we will be organising an interesting range of seminars for 2010. We will also look to encourage new members and help communicate the benefits of ISPE membership” Pharmaceutical Manufacturing Engineer - Europe Zogenix is a specialty pharmaceutical company whose goal is to uniquely enhance and differentiate medicines by incorporating innovative technologies in an effort to relieve suffering in people with CNS and pain disorders Zogenix is currently seeking an experienced, highly motivated Pharmaceutical Manufacturing Engineer to play a key role in ensuring commercial manufacturing processes and equipment located in Europe consistently deliver DosePro product to the market according to the approved production plan, quality requirements, and cost targets. This position will report to the Director of European Operations, and is located in the U.K. The successful candidate will have: Qualified to Degree level in Engineering (Mechanical, Chemical, Electrical Engineering strongly preferred) Minimum of 8-10 years experience with processes in a production environment, at least 5 in a aseptic pharmaceutical environment. Significant experience working with third party vendors and contract manufacturers in a role requiring relationship building. The candidate must have experience with validation of automated equipment, and familiarity with cGMP/Regulatory aspects of aseptic filling processes. Ability to travel up to 25-50% of time If you desire to make a difference and are looking for a unique and challenging career opportunity please send your resume to: hr@zogenix.com Be a part of an emerging industry leader with Zogenix! NOTES FROM THE EDITOR - JON YOULES There have been a lot of changes to the organising committees since the previous newsletter and each Regional Chair will be looking to organise events to support the industry in the face of significant changes within manufacturing. The ISPE needs the active participation of the Membership to ensure the UK industry continues and thrives and we would encourage you to take part by attending or contributing to the local events. Any company interested in supporting the UK Affiliate whilst reaching the readership of the ISPE UK Newsletter is invited to contact me about advertising within this Newsletter My contact details are - Tel: 01494 792898 - Mobile: 07711 633105 - Email: jony@ytron-quadro.co.uk ISPE INFO UPDATE - NEW NORTHWEST REGIONAL CHAIR Lynn Bryan Lynn Bryan of Ballygan consulting has recently been appointed Chair of the North West region, taking over from Steve Riley. Lynn is currently working on QP release of sterile radiopharmaceuticals and has a broad range of experience within the pharmaceutical industry working in manufacturing and as a consultant. Lynn has worked making blood products and vaccines, sterile products, freeze dried products, tablets, capsules and aerosols (MDI’s, DPI’s, pump sprays). Prior to this Lynn was the director of an independent validation company and has also worked for Welcome and Fisons in both production and QA roles. Lynn been actively involved with the ISPE Northwest Committee for 10 years and worked on the UK affiliate as ISPE European Education Liaison for 2 years. During this time she has been involved in presenting training courses on validation, training approach, GMP and systems. water/steam One of Lynn’s key goals is to meet the needs of the membership and Lynn says she is “looking forward to working with the North West Committee to develop a strong programme of events in the coming year providing interesting and informative evening seminars and visits to ensure members feel they receive value for money from their ISPE membership” DIARY OF EVENTS 2010 The provisional plans are currently under development. More details are available on the ISPE website Central Region Chair - Steve Boswell Tel: 07891 485368 Email: sboswell@s3process.com Jun 2010: Sustainability Seminar Location: Siemens Turbines, Lincoln Sep 2010: Containment Seminar Location: TBC Oct 2010: Continuous Processing Seminar. Location: TBC North East Region Chair - Bruce Williams Tel: 07944 766 508 Email: bruce@williamsprocess.co.uk Jun 2010: Sustainability Afternoon half day seminar. Location: Newcastle University Sep 2010: Biotech Seminar Evening seminar and networking opportunity in partnership with NEPIC Location: Bracknell Details to be confirmed 20 Oct 2010: Process and Utility Steam. Q4 2010: GAMP seminar Seminar and demonstration Details to be confirmed Location: Spirax Sarco North West Region 18 Nov 2010 – SUSTAINABILITY – Chair - Lynn Bryan Applications of the Principles in Tel: 07970 004620 the Pharmaceutical Industry Awards Dinner and Conference Email: lynn@ballygan.com Location: Heathrow 7 Jul 2010: Forum Evening Details tbc Q4 2010 – BRITEST Location: TBC 22nd Sep 2010: Innovations in Water and Steam. Details tbc Nov 2010: Packaging seminar PPMA EVENTS & NEWS Details tbc Southern Region Chair - Alan Halstead Tel: 07879 432 587 Email: Alan.Halstead@pmg.co.uk 16 Jun 2010: GAMP – Meeting the Challenges of Regulatory Evolution Seminar and practical demonstration TOTAL Processing and Packaging 2010 at the NEC 25th - 27 May 2010 PPMA Ltd. Tel: 020 8773 8111 www.ppma.co.uk SUSTAINABILITY Application of the Principles in the Pharmaceutical Industry S U S T A I N A B I L I T Y What is Sustainability? It seems that there are wide-ranging views on the definition of sustainability but to quote Wikipedia it is: the ability to endure...The most widely quoted definition of sustainability and sustainable development, is that of the Brundtland Commission of the United Nation on March 20, 1987: “sustainable development is development that meets the needs of the present without compromising the ability of future generations to meet their own needs.” The 2010 Annual Awards Conference will look at how the Pharmaceutical industry is currently meeting the challenges of Sustainability and how we can adopt principles of Sustainability in both Facilities and Processes in the future. With leading speakers from Manufacturing and Engineering groups presenting papers on the latest developments and how the most up to date facilities have performed, delegates to the conference will learn the latest Sustainability developments in our industry sector and have opportunity to interact with the speakers and other delegates as well as the conference Exhibitors. The conference will also have input from outside the industry where innovative approaches in projects such as 2012 Stratford City Regeneration Project and the Salford Quays Regeneration Project 'Media City' may provide new ideas for Sustainable construction in the pharmaceutical sector. Agenda 08:00 09:00 Registration / Coffee / Exhibition Welcome introduction Conference Chair: Bruce Davis, Principal Consultant, Global Consulting Southern Regional Cairman: Alan Halstead 09:20 Keynote Address 09:55 Leadership in Sustainability: insight from a construction company perspective Richard Parmenter, Vice President GMS Head of Engineering and EHS, GSK Dr Paul Toyne, Head of Sustainability, Bovis Lend Lease and London Sustainable Development Commissioner. 10:30 10:40 11:00 Sustainable Facilities CoP update Coffee break and exhibition ISPE Facility of the Year for Sustainability: Centocor Biologics Ireland update one year on 11:35 Sustainable Design for Complex Facilities 12:05 Sustainability – The European Perspective 12:35 13:50 Lunch and Exhibition Sustainable Pharmaceutical Manufacturing 14:20 Pfizer approach to Green Manufacturing 14:50 15:10 Coffee break and exhibition Process and Sustainability 15:40 Genzyme Sustainable Green Chemistry 16:10 Summary and Q&A session Conference close at 16:30 Con Leddy, PM Group Associate Director, Group Sustainable Energy Engineering Speaker to be confirmed Mike Murray, Technical Affairs Manager, ABPI Speaker to be confirmed Speaker to be confirmed Speaker to be confirmed Dr Peter McDonnell, Technical Director, Genzyme The Agenda is still under development and timings and topics may be subject to revision. SUSTAINABILITY Application of the Principles in the Pharmaceutical Industry S U S T A I N A B I L I T Y The Annual Awards Conference, Exhibition and Dinner 18th November 2010 The Annual Awards Conference, Exhibition and Awards Dinner will take place at the Park Inn Hotel, Heathrow, London on the 18th November 2010 and will be organised by the Southern regional committee under its Chairman Alan Halstead. The title of the Conference is: "Sustainability - Application of the Principles in the Pharmaceutical Industry" Plans for the event are well underway and Booking for the Conference and Dinner can be made now. A booking form for the conference is included in this newsletter. Sponsors for the event are: Bovis Lend Lease Faithful & Gould C21C MRC Systems Cyril Sweett Matini Group Energy and Carbon Reduction Solutions PM Projects We would be pleased to hear from any company who would like to become a sponsor of the event. There are still a small number of table top Exhibition spaces available and these can be booked with The Event Bookers or a reservation form can be downloaded via the ISPE website www.ispe.org/uk For any booking details or any queries regarding the event, please contact: The Event Bookers Ltd, 6 Gorse Close, Locks Heath, Southampton. SO31 6XZ. Telephone 01489 571213. Fax. 01489 854599. E-mail. ispe@bookerevents.co.uk Don’t forget to visit the website - www.ispe.org/uk