Slide 1:FAS BIOPHARMACEUTICAL/ PHARMACEUTICAL TRAINING FACILITYCARRIGALINE, CO. CORK

VALERIE COWMAN FAS

Slide 2:PRESENTATION OVERVIEW

FAS - AN OVERVIEW FAS AND THE PHARMACEUTICAL SECTOR / BIOPHARMACEUTICAL SECTOR – INITIATIVES AT HOME AND ABROAD

Slide 3:Who/What is FÁS?

FÁS IS THE IRISH NATIONAL TRAINING AND EMPLOYMENT AUTHORITY GOVERNMENT BODY - 66 OFFICES, 20 TRAINING CENTRES NATIONWIDE

Slide 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."

Slide 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)

Slide 6:Service Types

Services to Business Training Services Employment Services Community Services

Slide 7:Sample of Services

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

Slide 8:INITIATIVES ABROAD

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

Slide 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

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

Slide 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

Slide 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

Slide 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

Slide 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.

Slide 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

Slide 16:REVISED PLANS – EQUIPMENT 2006

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.

Slide 17:REVISED PLANS - EQUIPMENT

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

Slide 18:REVISED PLANS – Future Equipment

Vial Line Centrifuge Disposable Mobile Vessel Blister Packaging line Lyophiliser

Slide 19:HOW?

CONTRACT TRAINING PROVIDERS FACILITY FOR LEASE TO UCC /CIT LEASE TO COMPANIES FOR PRIVATE USE – CAN USE YOUR OWN TRAINERS

Slide 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

Slide 21:PROPOSED PROGRAMME

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

Slide 22:PROPOSED PROGRAMMES

Programme contents to be reviewed by Industry Advisory group prior to approval.

Slide 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.

Slide 24:OPEN FOR BUSINESS 16th APRIL 2007

Slide 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

Slide 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