Agile Software development in QUMAS ( 931 KB)
Annex 11 and Part 11 Workshop ( 471 KB)
Lab Data Management ( 551 KB)
IBM Presentation ( 365 KB)
Outsourced Automation and Validation ( 536 KB)
QUMAS - Overview ( 483 KB)
Regulatory Intelligence and Update ( 124 KB)
Ward Security What we See ( 2 MB)
“Release the Genius - Profiting from home grown lifesciences expertise”
Release the genius ( 938 KB)
The EirGen story so far... ( 750 KB)
Schivo Group ( 750 KB)
“Serialization - Practical Considerations for Implementation”
|9 - February||Morning: Seminar “Project Management Supporting Business
Afternoon: Workshops (a selection of four 90 minute workshops – Technology Transfer Project Management The new ISPE guide – Project Management for the Pharmaceutical Industry Program Management in the Biotech Industry – “Setting up projects for business success” Project Risk Management)
Introducing the ISPE Project Management Good Practice Guide ( 964 KB)
Project Portfolio and Benefit Realization Management ( 1 MB)
Managing Successful Biologics Development Projects: Lessons, Tools and Techniques in an Alliance setting ( 828 KB)
Event Photos ( 21 MB)
|8 - March||
Plant Tour & Seminar
Presentation: "Sterile Manufacturing & Disposable Technology in the Pharma
|19 - April||Event: Seminar (Full day)
Title: “Driving Competitiveness in the Irish Pharmaceutical Industry and related sectors”
Seminar photos ( 13 MB)
Gala dinner photos ( 7 MB)
|27 - September||Plant visit and half day seminar:"Sharing Best
Practices in Medical Device"
Ivan Hanley, Vistakon ( 207 KB)
Lorraine Patridge, Horizon West ( 423 KB)
Nigel Paterson, Abbott ( 474 KB)
|3 - February||Plant Tour: Cordis Cashel||Event Photos ( 1 MB)||Tipperary|
|7 - April||Morning Plant Tour: Covidien - Afternoon Seminar "Driving Operational Excellence||Dublin|
|26 - May||Afternoon Seminar: "ENERGY REDUCTION AND ALTERNATIVE SOURCES IN THE PHARMA
Energy and Utilities ( 2 MB)
Recovering Energy ( 3 MB)
Overview of BS Energy Efficiency Program ( 6 MB)
|12 - February||Plant Tour: Pfizer Ireland Pharmaceuticals||Cork|
|30 - March||Seminar & Plant Tour: Pfizer (Irl), Grange Castle||Dublin|
|22 - April||Seminar & Gala Dinner: Maryborough House Hotel||Cork|
|18 - May||Seminar & Plant Tour: Carleton Hotel||Kinsale|
|21 - October||Seminar: ISPE Guidance Documents - What's New?||Cork|
|3/4-Nov-09||Joint PDA/Pharmachem Ireland||Dublin|
|10-Sept-09||"Risk Based Manufacture of Pharmaceutical Products" (Risk-MaPP)||Cork|
|12-Feb-09||Plant Tour - Novartis||Cork|
|02-April-09||Full Day Seminar & Workshop (Sustainable Energy Management in the Life Sciences)
ANNUAL GALA DINNER
Venue: Genzyme Ireland Ltd
Followed by: GOLF OUTING
Venue: Faithlegg Golf Club, Waterfod
|28 MAY 09||Event: Plant Tour||Allergan|
|25 June 09||Plant Tour: Allergan Pharmaceuticals||Westport, Co. Mayo|
|14-Feb-08||Seminar & Plant Visit (Biopharma. Manufacturing Facilities) Centocor Biologics||Cork|
|06-Mar-08||Evening Seminar & Workshop (Careers in Life Science professional devp.)||Dublin|
|17-Apr-08||Seminar & Gala Dinner (Pharmaceutical R&D collaboration academia & industry)||Cork|
|11-Sept-08||Plant Tour & Golf Outing (UCB / Schwarz)||Shannon|
|16-Oct-08||Workshop & Seminar & AGM (Regulatory Environment)||Dublin|
|Dec-08||Plant Tour (Pfizer Fill Finish, Dunlaoghaire, Dublin)||Dublin|
In 2007, the Ireland Affiliate held two successful events in Cork as follows:
15th February 2007 – Plant Tour, Pfizer Loughbeg
Over 20 people attended the tour of the recently commissioned 5000 m2 Spray Dryer Facility at Pfizer’s Loughbeg Plant in Cork . As usual, the attendees were drawn from all sectors of the industry in Ireland, and all were highly impressed by the facility.
ISPE Ireland Affiliate would like to extend our thanks once again to Mr. Iggy Marum, SDD Plant Manager for facilitating the tour, and for the courtesy displayed to our attendees.
8th March 2007 – Lab Design for the Pharma/Med Device Industry
ISPE Ireland once again descended in numbers on The Maryborough House Hotel in Douglas, Cork, for an extremely interesting and varied seminar on Lab Design. An attendance in excess of 60 people demonstrated the level of interest in the subject matter, and also validated the calibre of the seminar program put together by committee members Michael McLoughlin and Seamus Kelly.
The seminar, chaired by Joe Murphy from Centocor Biologics, opened with an overview of the ISPE Laboratory Baseline Guide, presented by Euan Smith of Organon, a key member of the ISPE team charged with the guide’s development. The presentation explained the development process involved, and provided a preliminary insight into the elements contained in the guide, and their current status. Curiously, Euan opened his presentation with an excerpt from a 1940’s design booklet, and many of the issues identified then are still prevalent today. Refreshingly, the emphasis on personnel safety has changed for the better in the interim.
Roy Long of Wyeth Grangecastle then presented an interesting account of some of the issues involved in Building Compliant Laboratories, and passed on the benefit of his experience in relation to some of the main issues involved.
Following a short break, Neil McGuinness of Elan delivered a very practical paper on Lessons Learned during Laboratory Design. Focusing on a number of Lab projects for which he was responsible, Neil outlined some of the difficulties involved in the design and construction phases, especially in space conversion to labs, and yet presented evidence that these had all been overcome satisfactorily, using engineering ingenuity in some cases.
Enjoying a well earned break in proceedings at Lab Design Seminar – Cork
In his presentation, Michael Lorenz of Kling Stubbins Architects, US, provided an excellent insight into the increasing level of sophistication and technology being utilised in Lab design. Clearly much of this is driven by the desire to have more environmentally friendly and energy efficient facilities, and Laboratories and their design have a part to play in that process.
Michael Lorenz illustrating some of the modeling tools used in Lab design
The seminar concluded with a presentation from Graham Guise, of PM Group, UK. Graham focused on the architectural aspects of lab design, and on the necessity to design from the inside out, placing the lab personnel and their requirements to the forefront. This view was well received by all present, and served as a gentle reminder to the engineering fraternity that there was more to lab design than HVAC and building services considerations!!
Michael McLoughlin thanked the Chairman and all the speakers on behalf of the ISPE Affiliate Committee, and especially Euan, Michael and Graham who had flown in specially for the event. He also reminded the attendees of the next Ireland Affiliate event in Dublin on April 19th. The event, a half day seminar on training in the Crowne Plaza Hotel at Dublin Airport will be followed by the Annual Gala Dinner at the same location.
Flyers for these events will be issued to all members in the coming weeks.
Event recently sponsored by ISPE Ireland:
Holy Rosary Primary School Science Week ( 185 KB)
Annual General Meeting
The Irish affiliate held their AGM at the Crowne Plaza Hotel in Dublin on Thursday 12th October 2006. Reflecting on another successful year for the affiliate, Chairman David Keenan was particularly encouraged by the increase in student members and the efforts to broaden the appeal of the affiliates activities to a wider audience within the industry. He thanked the committee for their commitment and professionalism throughout the year, and extended warm thanks to outgoing committee members Andy Rayner and Stephen Clune for their hard work during their terms of office.
The following officers were returned for 2007:
Chairman : David Keenan
Vice Chairman : Kyran Johnson
Secretary : Aidan Harrington
Treasurer : Mary Lennon
Seamus Kelly ( Project Management Ltd.) and Dara Kernan (Bristol Myers Squibb ) were elected to the committee in place of the outgoing members, with the rest of the committee returned for the coming year.
Pharmaceutical Documentation Seminar
A daylong event on Pharmaceutical Documentation was held immediately preceding the AGM on Thursday 12th October at the Crowne Plaza Hotel, Dublin.
Chaired by Dr. Aidan Harrington (Amgen Technology Ireland), and following the successful format of previous seminars, the day’s schedule consisted of a morning session of presentations, and an afternoon session comprised of facilitated roundtable workshops on topics of interest.
Over 40 people attended the seminar, which was very well received and attracted a high percentage of first time participants in an ISPE event.
Our thanks to the following speakers and facilitators:
Regina Mulhall ( Centocor)
Shirley Twohig & Lorraine O’Shea ( Pfizer Ringaskiddy )
Davina Geraghty ( BMS )
Jennifer O’Leary ( Wyeth GrangeCastle )
Arthur Stone ( Systematics )
Ian O’Toole ( BSM )
David Keenan ( Tyco Healthcare )
Special thanks also to Shane Breslin, Niall Duffy and Geraldine Loyer for a tremendous job in organising the seminar. This was reflected in the efficiency of the event, the level of interaction among the participants and the degree of satisfaction among all concerned afterwards.
On Thursday 16th November last, 30 people attended an afternoon site visit at Janssen Pharmaceutical Ltd’s facility at Little Island, Cork. The visit focused on Modules 1 and 2 of Janssen’s P3 plant. These are multi purpose bulk chemical trains forming part of a new 5000 m2 production facility which is currently in qualification.
Sincere thanks to Janssen for accommodating this interesting visit and for the courtesy and hospitality shown to our visitors.
Annual Planning Meeting:
The organising committee held its annual planning meeting at the Radisson Hotel, Little Island in the aftermath of the afternoons visit to Janssen. An exciting outline programme of events was agreed for 2007 comprising briefly of the following:
Some further details remain to be added to this list on possible additional events. The committee will meet once more in 2006, and will issue a confirmed programme of events for 2007 to all members early in the New Year.
Following the planning meeting, a dinner was held at the Radisson Hotel, Little Island to honour the contribution of Dr. Declan Scott to the ISPE Ireland Affiliate since its foundation. Declan was instrumental in setting up the Irish Affiliate, and gave many years of commitment, energy and advice up until his retirement from the post of Honorary President at the recent AGM. To Declan our heartfelt thanks, and our wishes for continued good health and happiness.