1. Wednesday 13 th February 2013 Ramside Hall, Durham Pharmaceutical Skills Development Steve Barker – Director of Corporate EHS Aesica Pharmaceuticals Limited NEPIC Skills Event

2. Wednesday 13 th February 2013 Ramside Hall, Durham MHRA “Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007” – the ORANGE GUIDE (internet for updates) Regulatory Requirements in the UK HSE COMAH MHRA/FDA/HSE inspections All the regulators look for demonstration of training and COMPETENCY ASSURANCE The requirement for continued training (skills development) is stipulated in regulations

3. Wednesday 13 th February 2013 Ramside Hall, Durham Job descriptions and responsibilities Role profiles Qualification and training requirements Cogent Gold Standards? Training records Testing and validation of training How to show competency?

4. Wednesday 13 th February 2013 Ramside Hall, Durham Engineering tradesmen Average age of Aesica’s mechanical fitters is 53 Previous low level of apprentice applications Apprentice providers struggle to provide appropriate course content Pharmaceutical Skills Gaps Experienced Process Engineers Competition from oil & gas sector Quality Assurance roles and QPs Shortage of qualified staff

5. Wednesday 13 th February 2013 Ramside Hall, Durham Retain Career development Job Share / Flexible working Addressing Skills Gaps & Regulatory Requirements Recruit Apprentices Work Experience Other Sectors Up-skill Broaden existing roles

6. Wednesday 13 th February 2013 Ramside Hall, Durham The Alternative ?