In-company IRCA Certified Pharmaceutical Auditor/Lead Auditor
Training
Inhouse
Description
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Type
Training
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Methodology
Inhouse
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Duration
5 Days
The company benefits are significant. The MHRA, FDA and other regulators report that the major causes of recalls of pharmaceutical products are due to purchased items. It is therefore imperative that supplier audits are done professionally so that you get a thorough understanding of how quality of critical supplies are managed. IRCA registration also confers professional auditing status. Suitable for: The course is designed for Quality Assurance, Quality Control and Purchasing Professionals from Pharmaceutical Companies and Suppliers. It is also very useful for auditors from third party certification bodies. In the UK, delegates have attended from BSI, DNV and SGS. The course is highly recommended to existing and intending Qualified Persons (QPs) as part of their Continuous Professional Development (CPD).
Important information
Government funding available
Reviews
Course programme
IRCA Pharmaceutical Auditor/Lead Auditor
This unique 5-day course is highly recommended for anyone concerned with the quality management systems operated by suppliers of starting materials to the pharmaceutical industry. It has been developed and run over many years in the UK, Europe and the Far East.
The course is based on GMP as it relates to starting materials and specified in the PS 9000 series of standards. 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, whilst oils for external ointments would have a lower level of GMP). These standards have been developed over more than 15 years and are published in the UK by the Pharmaceutical Quality Group (PQG) of the Institute of Quality Assurance (IQA). This is made up of quality executives from most of the major pharmaceutical companies and their suppliers. There is an associated certification scheme for company registration. The UK medicines regulator endorses the PS 9000 series and some of its inspectors have attended the course.
Additional information
BACS or Cheque
In-company IRCA Certified Pharmaceutical Auditor/Lead Auditor