This unique 5-day course is highly recommended for anyone concerned with the Quality Management System (QMS) operated by suppliers of starting materials and components to the pharmaceutical industry.
Who should attend?
- Quality assurance managers
- Quality control & purchasing professionals from pharmaceutical companies and suppliers
- Third party certification auditors
- Qualified Persons (QPs)
It has been developed and run over many years in the UK, Europe and the Far East and meets all of the training requirements for IRCA/PQG & RABQSA (Exemplar as now they are called) (auditor/lead auditor registration.
The course is based on GMP as it relates to materials specified in the PS 9000 series of standards, ISO 15378 and the ICH Q series. PS 9000 applies to contact and secondary packaging and printed components such as labels and patient information leaflets; PS 9100 specifies graded levels of GMP for inactive materials dependent upon their use (e.g. liquids for eye drops would have the same level as the GMP used by the pharmaceutical manufacturer, oils for external ointments would have a lower level of GMP).
ISO 15378 is the International Standard for Primary Packaging Materials.
These standards have been developed over more than 15 years and are published in the UK by the Pharmaceutical Quality Group of the Chartered Quality Institute (CQI) and the International Standards Organisation (ISO 15378). The PQG is made up of quality executives from most of the major pharmaceutical companies and their suppliers.
If you would like further information on this course please call us on +44 (0)1903 730622 or e-mail email@example.com
Run in association with JEMO Ltd