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Pharmaceutical Industry

 

The Pharmaceutical sector is the most regulated industry. Outcome Training Associates is currently, or has worked with the major pharmaceutical companies in Europe.

The industry faces more and more pressures.

  • Cost competiveness
  • Regulatory requirements
  • Competence
  • Mergers / takeovers
  • New workforce

The following case study highlights Outcome Training Associates' experience in the sector. For more details / client references please contact us by clicking here.

Due to the high level of regulation and the need to be audit ready 24/7 Outcome Training Associates Limited is often asked to consider whether the client meets the "best practice" standard for Training and Development (Learning and Development).

Some time ago a major client sought support to identify the range of training / learning needs of its' business. This process had to be designed to populate a mangement database which would stand the rigours of an FDA audit and the Global Corporate Strategy.

This resulted in:

  • Training Matrices for over 200 roles from Operators in process / packaging, to Operations Manager.
  • Training Needs Analysis for roles
  • Highlighting of regulatory issues
  • Inclusion of other teams
  • Warehouse
  • QO
  • Labs
  • Maintenance
  • HR / Procurement / L&D

The outcome has already highlighted and produced improvements in:

  • Induction training
  • cGMP training
  • Safety training
  • SOPs
  • Audit compliance
  • Other activities in the sector:
  • Train the Trainer
  • Assessor training
  • Development of Performance Standards
  • Lab training
  • Problem Solving
  • Design & Development of Training Materials

OTA provided a key input into supporting the Irish Finished Pharmaceutical sector in developing National Standards of Performance and Assessment under the European Adapt project.

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