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Case Study..a typical project

Background. . .the brief

A small company making cosmetics and medical devices is expanding into pharmaceutical manufacturing. Middle/Senior staff are in need of training in Medicines Laws, GMP/QA.

Induction training is also needed for the new operational staff (in the Medicines Manufacturing, Quality Control and Packaging groups).

Consultancy support. . .

Consultancy and advice can be provided in the following areas

Quality Management Systems
Procedures and Documentation
Application for a Manufacturing Authorisation (Manufacturers Licence)
Preparation for an Inspection
Sourcing/auditing of suppliers
Preparation of a Marketing Authorisation

Our Consultancy Services. . .

Training can be provided (as described in our training area of this website). An example of what may suit the above case is:

  • Training for middle/senior managers in Law, GMPs, Pharmaceutical Quality Management vs ISO9001 etc
  • Preparation of an induction module for new staters…initially presented to in house staff with the intention of them acting as in house trainers who present the modules to new staff
  • 1 to 1 Training of the the company trainers (including presentational skills, the use Powerpoint and the preparation of participative groupwork sessions)
  • Help to prepare/provision of a training record database and a database to record Quality Incidents/Deviations.