Wednesday 13th February 2013Ramside Hall, Durham

 

Pharmaceutical Skills Development

Steve Barker – Director of Corporate EHS

Aesica Pharmaceuticals Limited

NEPIC Skills Event

Wednesday 13th February 2013Ramside 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

Wednesday 13th February 2013Ramside 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?

Wednesday 13th February 2013Ramside 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

Wednesday 13th February 2013Ramside 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

Wednesday 13th February 2013Ramside Hall, Durham

 

The Alternative ?