FAS BIOPHARMACEUTICAL/ PHARMACEUTICAL TRAINING FACILITY CARRIGALINE, CO. CORK

1. FAS BIOPHARMACEUTICAL/ PHARMACEUTICAL TRAINING FACILITYCARRIGALINE, CO. CORK VALERIE COWMAN FAS

2. PRESENTATION OVERVIEW • FAS - AN OVERVIEW • FAS AND THE PHARMACEUTICAL SECTOR / BIOPHARMACEUTICAL SECTOR – INITIATIVES AT HOME AND ABROAD

3. Who/What is FÁS? FÁS IS THE IRISH NATIONAL TRAINING AND EMPLOYMENT AUTHORITY GOVERNMENT BODY - 66 OFFICES, 20 TRAINING CENTRES NATIONWIDE

4. MISSION STATEMENT 2006 - 2009: • "To promote a more competitive and inclusive knowledge-based economy, in collaboration with our stakeholders, by enhancing the skills and capabilities of individuals and enterprises."

5. Focus of Organisation • Learning for the workplace • Skill Development for those seeking employment. • Upgrading of existing skills for those in employment.( One Step Up / Competency Development Programme)

6. Service Types • Services to Business • Training Services • Employment Services • Community Services

7. Apprenticeship Training Courses Traineeships Competency Development Programme Sector specific programmes e.g. Pharmachem, Retail programmes. Sample of Services

8. INITIATIVES ABROAD • JUNIOR SCIENCE CHALLENGE ( past programme) • SCIENCE CHALLENGE • OVERSEAS GRADUATE PROGRAMME Further Information: www.fas.ie

9. INITIATIVES 1999 -2007 (IN IRELAND) • INITIATIVE 1 National Occupational Standard Framework A certified competence model for operations personnel in the pharmachem and medical device sectors • INITIATIVE 2 Cabra Programme – A certified training programme for operations personnel in the pharmachem / bio pharma sector - heavy use of ICT, elearning and simulation of process plant • INITIATIVE 3 Carrigaline A training facility where operations personnel can gain the hands on practical skills required in the biopharma / pharmachem industries – heavy emphasis on production scale equipment and vocational skill development

10. FAS BIOPHARMACEUTICAL/ PHARMACEUTICAL TRAINING FACILITYCARRIGALINE, CO. CORK

11. WHAT ? • A ‘hands on’ training facility where people can gain the practical skills required to work in the pharmaceutical/ bio –pharmaceutical sector • Multi - million Euro investment

12. WHERE? • Exact location –Estuary Industrial Park, Crosshaven Road, Carrigaline, Co. Cork. • Site size – current building footprint approximately 1500 square metres • There is scope for expansion on this site, FAS have first refusal on this

13. TARGET AUDIENCE? • OPERATORS / CRAFTS – SKILLING AND UPSKILLING • Existing operators/ crafts people who require updating or cross skilling • Redundant workers from related industries • New entrants to the labour market who aspire to work in these sectors

14. INITIAL PROPOSED LAYOUT • 4 classrooms • CIP/ SIP Skid • Fermentation skid • Mixing and Blending skid • Process Control skid • Clean room • Automation area • Canteen, warehouse etc.

15. REVIEW OF PLANS • Industry advisory group put in place Dec 2005 • 5 companies involved – 3 API, 1 bio – pharma, 1 finished. • Brief of the group – review layout, review proposed equipment list, review proposed programmes

16. Generic Reactor skid Mixing and blending vessel Glassware skid – pumping, heating, in process, CIP Skid Glove box with weighing scales, CIP Flexible Powder transfer containment system Mill with charge and discharge system & hopper Large scale chromatography & U/F rig Autoclave DI generation skid Display WFI generation Filters – HEPA, Cartridge etc. Various other smaller items – pumps, valves, pipes, o rings, heat exchangers, samplers, column internals, PPE etc. REVISED PLANS – EQUIPMENT 2006

17. Classrooms – 4 Clean room Clean room change Utilities area – for provision of purified water, clean steam Audio/ video / computer lab Canteen FACILITY WILL MIMIC A GMP CONTROLLED SITE BUT WILL NOT BE CLASSIFIED REVISED PLANS - EQUIPMENT

18. Vial Line Centrifuge Disposable Mobile Vessel Blister Packaging line Lyophiliser REVISED PLANS – Future Equipment

19. HOW? • CONTRACT TRAINING PROVIDERS • FACILITY FOR LEASE TO UCC /CIT • LEASE TO COMPANIES FOR PRIVATE USE – CAN USE YOUR OWN TRAINERS

20. REVISED PLANS - PROGRAMMES • BUILD ON EXISTING PROGRAMMES – DON’T CREATE SOMETHING NEW • TRANSPARENT FRAMEWORK FOR PROGRESSION • MODULAR – TO ALLOW FLEXIBILITY • ALL ASPECTS OF FACILITY AVAILABLE TO DO PRACTICAL TRAINING – INCLUDING UTILITIES

21. PROPOSED PROGRAMME CORE SKILLS PROCESS SKILLS API / BULK CHEMICAL BIO- PHARMACEUTICAL FINISHED PHARMA ALL MODULES CAN BE COMPLETED AND ACCREDITED SEPARATELY

22. PROPOSED PROGRAMMES • Programme contents to be reviewed by Industry Advisory group prior to approval.

23. LINKS • FAS has signed a memorandum of understanding with NIBRT (National Institute for Bio – processing Research and Training), CIT and UCC • NIBRT and FAS will support each others activities and link where necessary to provide complementary programmes.

24. OPEN FOR BUSINESS 16th APRIL 2007

25. Summary • Skills Competence in the workplace to competence pre the workplace • Pharmachem to Biopharma • Certification of Skills – Linking to the National framework • Career progression and development pathways for the individual

26. CONTACTS Valerie Cowman – 087 637 1858 / 021 485 6234 Valerie.cowman@sw.fas.ie Jerry Linehan – 087 637 1857 / 021 485 6331 jerry.linehan@sw.fas.ie Enda McWeeney – 087 126 2247 / 021 485 6223 Enda.mcweeney@sw.fas.ie